International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) (ISCHEMIA)

May 30, 2023 updated by: NYU Langone Health

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT.

SPECIFIC AIMS

A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT.

B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints.

Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH

Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH

Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Evidence supporting a routine invasive practice paradigm for patients with SIHD is outdated. In strategy trials conducted in the 1970s, coronary artery bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with high-risk anatomic features. The relevance of these studies today is speculative because contemporary secondary prevention-aspirin, beta-blockers, statins, ACE inhibitors, and lifestyle interventions-were used minimally if at all. Subsequent trials have compared percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce death or myocardial infarction (MI) compared with medical therapy in SIHD patients.

COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical therapy in SIHD patients, found that among patients selected on the basis of coronary anatomy after cardiac catheterization, an initial management strategy of coronary revascularization (PCI, PCI or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine cardiac catheterization--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had ischemia severity documented at baseline had only mild or moderate ischemia, leaving open the question of the appropriate role of cardiac catheterization and revascularization among higher-risk patients with more severe ischemia. Observational data suggest that revascularization of patients with moderate-to-severe ischemia is associated with a lower mortality than medical therapy alone, but such data cannot establish a cause and effect relationship. In clinical practice only about half such patients are referred for cardiac catheterization, indicating equipoise. Furthermore, analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline did not reveal a benefit from PCI. This issue cannot be resolved using available data because all prior SIHD strategy trials enrolled patients after cardiac catheterization, introducing undefined selection biases (e.g., highest risk patients not enrolled) and making translation of study results problematic for clinicians managing patients who have not yet had cardiac catheterization.

A clinical trial in SIHD patients uniformly at higher risk (which could not have been performed before COURAGE and BARI 2D results were available) is needed to inform optimal management for such patients.

DESIGN NARRATIVE, INCLUDING MODIFICATIONS DURING THE TRIAL

Primary Endpoint

A composite of CV death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure was proposed as the primary endpoint in the application that was funded by NLHBI, with a secondary endpoint of CV death or MI. Study protocol version 1.0 was finalized on January 18, 2012 after review and approval by the protocol review committee (DSMB) with the primary endpoint specified as the composite of CV death or MI. Regarding the final status of the primary endpoint, the protocol stated:

"To ensure that the primary analysis is well-powered and useful, a prospective plan to allow extending follow-up and/or changing the primary endpoint based on aggregate event rate data will be established prior to the first review of unblinded trial data. At a designated time during the trial, an analysis will be conducted to estimate the overall aggregate primary endpoint event rate and project the final number of observed events. If the estimated unconditional power (i.e. based on aggregate event rate data; not by treatment group) is less than the originally targeted 90%, then one or more of the following options will be considered:

  1. Extend follow-up to allow more events to accrue.
  2. Change the primary endpoint to one that occurs more frequently. The current primary endpoint would become a secondary endpoint. The proposed new primary endpoint would be the composite of CV death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure.
  3. Follow the recommendation of an independent advisory panel. An independent advisory panel, separate from the DSMB, will be convened for the purpose of reviewing unconditional power estimates and making a recommendation to the NHLBI Director. Members of this panel will not have access to unblinded data by treatment group or other data that may bias their recommendation." All 5 event types were adjudicated throughout the trial. Study protocol v2.0 (January 2014) allowed ischemia eligibility by non-imaging exercise stress test if more stringent (≥70% stenosis) CCTA criteria were met. The 2016 protocol addendum describes the NHLBI-approved reduction in sample size and extension of recruitment and follow-up due to slower than projected recruitment.

The pre-specified first analysis for monitoring and projecting the final aggregate number of primary endpoint events was conducted in 2015. In 2016, the projected need to increase the power by extending follow-up and elevating the 5-component secondary endpoint to become primary was discussed at Steering Committee and Investigator meetings and communicated by email.

An Independent Advisory Panel convened by NHLBI met in May 2017, and in June 2017 NHLBI approved the Independent Advisory Panel's recommendation to elevate the 5-component secondary endpoint to become primary and retain the 2-component composite as a key secondary endpoint. The panel also recommended extension of follow-up. This was communicated to the Steering Committee and Investigators at August and November 2017 meetings and by email. The last visit date was June 30, 2019.

A statistical plan developed for the Independent Advisory Panel process in 2012 specified that a decision about changing the primary endpoint would be targeted to occur before 75% of the final number of primary endpoint events had accrued. Although the final number of primary endpoint events was unknown during the course of the trial, estimates performed at the time of the Advisory Panel meeting suggested that the ratio of accrued endpoint events to final endpoint events was below 50%. See Maron DJ et al. Am Heart J. 2018 201:124-135. PMC6005768 for additional details about modifications to the trial while it was being conducted.

Analysis of Patients' Health Status as a Key Secondary Endpoint

A key secondary objective of the ISCHEMIA trial is to compare the quality of life outcomes-patients' symptoms, functioning and well-being-between those assigned to an invasive strategy as compared with a conservative strategy. In the protocol, angina frequency and disease-specific quality of life measured by the Seattle Angina Questionnaire (SAQ) Angina Frequency and Quality of Life scales, respectively, are described as the tools that will be used to make this comparative assessment. Recent work has indicated that it is possible to combine the information from the individual domain scores in the SAQ into a new Summary Score that captures the information from the SAQ Angina Frequency, Physical Limitation and Quality of Life scales into a single overall score. The advantages of using a summary score as the primary measure of QOL effects of a therapy are a single primary endpoint comparison rather than two or three (eliminating concerns some may have about multiple comparisons) and a more intuitive holistic (patient-centric) interpretation of the effectiveness results. With these advantages in mind, the ISCHEMIA leadership has agreed that the SAQ Summary Score will be designated as the primary way this outcome for this key secondary endpoint of the ISCHEMIA trial will be analyzed and interpreted, with the individual SAQ scores being used in a secondary, explanatory and descriptive role.

PARTICIPATING COUNTRIES:

North America:

Canada; Mexico; USA

South America:

Argentina; Brazil; Peru

Asia:

China; India; Japan; Malaysia; Singapore; Taiwan; Thailand; Russian Federation

Pacifica:

Australia; New Zealand

Europe:

Austria; Belgium; France; Germany; Hungary; Italy; Lithuania; Macedonia; Netherlands; Poland; Portugal; Romania; Serbia; Spain; Sweden; Switzerland; UK

Middle East:

Egypt; Israel; Saudi Arabia

Africa:

South Africa

Study Type

Interventional

Enrollment (Actual)

5179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Clinica del Prado
      • Cordoba, Argentina, 5000
        • Clinica Romagosa and Clinica De La Familia
      • Cordoba, Argentina, 5000
        • Clínica Privada Vélez Sarsfield
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina, 8000
        • Hospital Italiano Regional del Sur Bahia Blanca
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1093AAS
        • Fundacion Favaloro
    • CBA
      • Cordoba, CBA, Argentina, 5009
        • Instituto Médico DAMIC
  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • John Hunter Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Flinders Medical Centre
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
    • Stmk
      • Graz, Stmk, Austria, 8020
        • LKH Graz West Austria
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medical University of Vienna, Department of Cardiology
      • Vienna, Wien, Austria, A-1160
        • Wilhelminen Hospital Vienna
  • Belgium
    • Brabant
      • Leuven, Brabant, Belgium, 3000
        • University Hospital Leuven
  • Brazil
      • Salvador, Brazil, BA, 41820-011
        • Hospital Da Bahia
      • Sao Paulo, Brazil, 04025-011
        • UNIFESP - Hospital Sao Paulo
      • Sao Paulo, Brazil, 05403-000
        • Heart Institute (Incor) University of Sao Paulo
      • Sao Paulo, Brazil, 13059-740
        • Hospital Celso Pierro
    • Bahia
      • Salvador, Bahia, Brazil, 41810-010
        • Fundacao Bahiana de Cardilogia
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-921
        • Hospital Lifecenter
      • Pocos de Caldas, Minas Gerais, Brazil, 37701-045
        • Hospital Maternidade E Pronto Socorro Santa Lucia
    • Parana
      • Curitiba, Parana, Brazil, 80045-170
        • Quanta Diagnostico & Terapia
      • Curitiba, Parana, Brazil, 80320-320
        • Hospital Cardiológico Costantini
    • RS
      • Fundo, RS, Brazil, 99010080
        • Hospital São Vicente de Paulo
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
    • Rio De Janeiro
      • Botafogo, Rio De Janeiro, Brazil, 22280-020
        • Hospital Pro-Cardiaco
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sol
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
        • Instituto de Cardiologia de Porto Alegre
    • SP
      • Sao Paulo, SP, Brazil, 1418100
        • Hospital TotalCor
    • Sao Paulo
      • Ibirapuera, Sao Paulo, Brazil, 04012-909
        • Instituto Dante Pazzanese de Cardiologia
      • Ribeirao Preto, Sao Paulo, Brazil, 14048-900
        • Hospital Das Clinicas Da Faculdade De Medicina De Ribeirao Preto da Universidade de Sao Paulo
  • Canada
      • Ottawa, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • Grimsby, Ontario, Canada, L3M 1P3
        • West Lincoln Memorial Hospital
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Mississauga, Ontario, Canada, L4W 0C2
        • Dixie Medical Group
      • Oshawa, Ontario, Canada, L1J 2K1
        • Dr. James Cha
      • Scarborough, Ontario, Canada, M1E 5E9
        • Scarborough Cardiology Research
      • St. Catharines, Ontario, Canada, L2S0A9
        • Saint Catharines General Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network
      • Toronto, Ontario, Canada, M5G 1N8
        • Women's College Hospital
      • Vaughan, Ontario, Canada, L4H0P6
        • Northwest GTA Cardiovascular and Heart Rhythm Program
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montréal, Quebec, Canada, H4J 1C5
        • Centre Intégré Universitaire de Santé et de Services Sociaux du Montréal
      • Terrebonne, Quebec, Canada, J6V 2H2
        • CISSSL - Hopital Pierre-Le Gardeur
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Centre Hospitalier de Regional Trois-Rivieres
  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100037
        • Chinese Academy of Medical Sciences, Fuwai Hospital
      • Beijing, Beijing, China, 100020
        • Beijing Chao-Yang Hospital, Capital Medical University
    • Chaoyang
      • Beijing, Chaoyang, China, 100029
        • Beijing Anzhen Hospital
    • Fangshan
      • Beijing, Fangshan, China, 102401
        • Liangxiang Hospital, Beijing Fangshan District
    • Guangdong
      • Guangzhou, Guangdong, China, 510100
        • Guangdong General Hospital
    • Hebei
      • Tangshan, Hebei, China, 063000
        • Tangshan Gongren Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Asia Heart Hospital
      • Wuhan, Hubei, China, 430030
        • Tongji Medical College
      • Wuhan, Hubei, China
        • Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Affiliated Zhongshan Hospital of Dalian University
    • Shandong
      • Jining, Shandong, China, 272000
        • Affiliated Hospital of Jining Medical University
      • Qingdao, Shandong, China, 266071
        • Qingdao Fuwai Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030024
        • Shanxi Cardiovascular Hospital
      • Xian, Shanxi, China, 710000
        • Shanxi Provincial People's Hospital
    • Tianjing
      • Tianjing, Tianjing, China, 300457
        • Teda International Cardiovascular Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • First Affiliated Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Egypt
      • Cairo, Egypt, 11562
        • Cairo University
  • France
    • Centre
      • Chatres, Centre, France, 28018
        • C.H. Louis Pasteur
    • Ile De France
      • Boulogne, Ile De France, France, 92100
        • Ambroise Paré Hospital
      • Corbeil-Essonnes cedex, Ile De France, France, 91100
        • Centre Hospitalier Sud Francilien
    • Ile-de-France
      • Clamart Cedex, Ile-de-France, France, 92141
        • Antoine-Béclère Hospital
      • Paris, Ile-de-France, France, 75018
        • Bichat hospital
    • Isere
      • Grenoble, Isere, France, 38700
        • Grenoble University Hospital
    • Pays De La Loire
      • Angers Cedex 9, Pays De La Loire, France, 49933
        • Centre Hospitalier Universitaire d'Angers
  • Germany
    • BW
      • Stuttgart, BW, Germany, 70376
        • Robert-Bosch-Krankenhaus
    • NRW
      • Bonn, NRW, Germany, 53105
        • Universitatsklinikum Bonn
    • Saxony
      • Dresden, Saxony, Germany, D-01099
        • Praxisklinik Herz Und Gefaesse
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • University Hospital Jena
  • Hungary
      • Budapest, Hungary, 1097
        • Eszszk- Szent Istvan Hospital
      • Budapest, Hungary, 1117
        • Military Hospital, Budapest
      • Budapest, Hungary, 1122
        • Heart and Vascular Center, Semmelweis University
      • Budapest, Hungary, H-1096
        • George Gottsegen National Institute of Cardiology
    • Szeged Megyei Varos
      • Szeged, Szeged Megyei Varos, Hungary, 6720
        • University of Szeged
  • India
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
    • AP
      • Hyderabad, AP, India, 500020
        • Gurunanak CARE Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Care hospital
    • Delhi
      • New Delhi, Delhi, India, 110001
        • Dr Ram Manohar Lohia Hospital
      • New Delhi, Delhi, India, 110025
        • Fortis Escort Heart Institute
      • New Delhi, Delhi, India, 110062
        • Batra Hospital and Medical Research Centre (BHMRC)
      • New Delhi, Delhi, India, 110070
        • Fortis Healthcare Fl.t Lt. Rajan Dhall Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560069
        • Sri Jayadeva Institute of Cardiovascular Sciences and Research
    • Kerala
      • Calicut, Kerala, India, 673008
        • Government Medical College
      • Kolenchery, Kerala, India, 682311
        • MOSC Medical College Hospital, Kolenchery
      • Trivandrum, Kerala, India, 695011
        • Sree Chitra Tirunal Institute for Medical Sciences and Technology
    • Maharashtra
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic,Grant Medical Foundation
      • Pune, Maharashtra, India, 411011
        • KEM Hospital Pune
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Hero DMC Heart Institute, Dayanand Medical College and Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600081
        • Apollo Research and Innovation
      • Pondicherry, Tamil Nadu, India, 605006
        • Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
    • Telangana
      • Hyderabad, Telangana, India, 500001
        • CARE Nampally
      • Hyderabad, Telangana, India, 600081
        • Apollo Research & Innovations
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • King George's Medical University, Department of Cardiology
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Tel-Aviv, Israel, 67891
        • Assuta Medical Centers
  • Italy
      • Aosta, Italy, 11100
        • Ospedale Regionale Umberto Parini
      • Naples, Italy, 80121
        • Clinica Mediterranea
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
    • Campania
      • Napoli, Campania, Italy, 80131
        • AORN Dei Colli "V. Monaldi" UOC Cardiologia Università della Campania "L.Vanvitelli"
    • Emilia-Romagna
      • Forli, Emilia-Romagna, Italy, 47100
        • Ospedale "G.B. Morgagni - L. Pierantoni" Forli (AUSL della Romagna)
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • IRCCS "Casa Sollievo della Sofferenza"
    • MB
      • Monza, MB, Italy, 20900
        • Policlinico di Monza, Monza MB
    • Marche
      • Ancona, Marche, Italy, 60020
        • Cardiology and CCU - Ospedali Riuniti Ancona
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Humanitas Research Hospital, Rozzano (MI)
    • Piemonte
      • Cuneo, Piemonte, Italy, 12100
        • Azienda Ospedaliera S. Croce e Carle
    • Tuscany
      • Pescia, Tuscany, Italy, 54100
        • UO Cardiologia Ospedale SS Cosma e Damiano
    • Udine
      • Tolmezzo, Udine, Italy, 33028
        • Azienda Servizi Sanitaria n.3 Alto Friuli-Collinare-Medio Friuli
    • Veneto
      • Padua, Veneto, Italy, 35100
        • University of Padua- Cardiology Clinic
  • Japan
    • Osaka
      • Suita-shi, Osaka, Japan, 565-8565
        • National Cerebral and Cardiovascular Center
    • Saitama
      • Hidaka, Saitama, Japan, 350-0495
        • Saitama Medical University
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
  • Lithuania
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santariskes Clinic
  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50400
        • Institut Jantung Negara
  • Mexico
    • DF
      • Benito Juarez, DF, Mexico, 3100
        • Instituto Mexicano del Seguro Social
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Instituto Nacional de Cardiología "Ignacio Chávez"
  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboudumc
      • Zwolle, Netherlands, 8025 AB
        • Isala Klinieken
    • NH
      • Amsterdam, NH, Netherlands, 1091 AC
        • Cardio Research Hartcentrum OLVG
  • New Zealand
      • Auckland, New Zealand, 1142
        • Auckland City Hospital
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato Hospital
  • North Macedonia
    • Republic Of Macedo
      • Skopje, Republic Of Macedo, North Macedonia, 1000
        • University Clinic of Cardiology
  • Peru
    • Lima
      • Miraflores, Lima, Peru, 18
        • Instituto Neuro Cardiovascular De Las Americas
  • Poland
      • Poznan, Poland, 61-848
        • Szpital Kliniczny Przemienienia Pańskiego
      • Wroclaw, Poland, 50-981
        • Military Hospital / Medical University
    • Dolny Śląsk
      • Wrocław, Dolny Śląsk, Poland, 54-090
        • T.Marciniak Hospital
    • Lodzkie
      • Lodz, Lodzkie, Poland, 91-425
        • Cardiology Clinic, Medical University in Lodz
    • Maopolskie
      • Krakow, Maopolskie, Poland, 31-200
        • Department of Coronary Disease, John Paul II Hospital, Jagiellonian University Medical College
    • Mazovian
      • Warsaw, Mazovian, Poland, 04-628
        • Institute of Cardiology, Warsaw
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 04-628
        • Coronary and Structural Heart Diseases Department, Institute of Cardiology
      • Warsaw, Mazowieckie, Poland, 04-628
        • Department of Interventional Cardiology & Angiology, Institute of Cardiology
      • Warsaw, Mazowieckie, Poland, PL-02-097
        • Medical University of Warsaw
      • Warszawa, Mazowieckie, Poland, 02-005
        • Department of Internal Medicine and Cardiology, Infant Jesus Teaching Hospital, Medical University of Warsaw
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-276
        • University Hospital in Bialystok
    • Wojewodztwo Slaskie
      • Zabrze, Wojewodztwo Slaskie, Poland, 41-800
        • Medical University of Silesia, School of Medicine with the Division of Dentistry, Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases
  • Portugal
      • Lisboa, Portugal, 1150-291
        • Hospital de Santa Marta
      • Lisbon, Portugal, 1649-028
        • Santa Maria University Hospital, Cardiology Department, CHLN
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
  • Romania
      • Baia Mare, Romania, 021967
        • Emergency County Hospital Baia Mare
      • Bucharest, Romania, 022328
        • Emergency Institute of Cardiovascular Diseases ''Prof. Dr. C. C. Iliescu''
  • Russian Federation
      • Saint Petersburg, Russian Federation, 199106
        • North-Western State Medical University
      • Saint-Petersburg, Russian Federation, 197341
        • Federal Almazov North-West Medical Research Centre
    • Gorod Moskva
      • Moscow, Gorod Moskva, Russian Federation, 121552
        • National Medical Research Center for Cardiovascuar Surgery
    • Novosibirskaya Oblast
      • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630055
        • E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
  • Saudi Arabia
    • Central Province
      • Riyadh, Central Province, Saudi Arabia, 11426
        • King AbdulAziz Cardiac Center
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • Faculty of Medicine, University of Belgrade; Cardiology Clinic, Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • University Clinical Hospital Zvezdara
      • Belgrade, Serbia, 11000
        • University Hospital Center Bezanijska kosa
      • Kragujevac, Serbia, 11000
        • Clinical center Kragujevac
      • Nis, Serbia, 18000
        • Clinic for Cardiovascular Diseases, Clinical Center Nis
    • Vojvodina
      • Sremska Kamenica, Vojvodina, Serbia, 21204
        • Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica, Serbia and Faculty of Medicine, University of Novi Sad
  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 169609
        • National Heart Centre Singapore
      • Singapore, Singapore, 119228
        • National University Heart Center Singapore
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7945
        • Groote Schuur Hospital / University of Cape Town
  • Spain
      • A Coruna, Spain, 15008
        • Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas, Department of Cardiology. INIBIC A Coruña. CIBER-CV. Universidad de A Coruña, Spain
      • Barcelona, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08907
        • Hospital De Bellvitge
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28046
        • Hospital La Paz. IdiPaz
      • Murcia, Spain, 30120
        • HUVA, Hospital Clínico Universitario Virgen De La Arrixaca
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Hospital Clinico Universitario de Santiago
  • Sweden
      • Stockholm, Sweden, S-18288
        • Karolinska Institutet at Danderyd Hospital
      • Uppsala, Sweden, SE-751 85
        • Uppsala University
  • Switzerland
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Cardiocentro
  • Taiwan
      • Taipei City, Taiwan, 10449
        • MacKay Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
    • Meung
      • Chiang Mai, Meung, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, EC1A 7BE
        • University College London Hospitals NHS Foundation Trust/Barts Health NHS Trust
      • London, United Kingdom, SE13 6LH
        • King's College NHS Foundation Hospital
      • London, United Kingdom, W12OHS
        • Imperial College Healthcare NHS Trust
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospital
    • Antrim
      • Belfast, Antrim, United Kingdom, BT12 6BA
        • Belfast Trust
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK42 9DJ
        • Bedford Hospital NHS Trust
    • Berdfordshire
      • Luton, Berdfordshire, United Kingdom, LU4 0DZ
        • Luton and Dunstable University Hospital NHS FT
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
        • Papworth Hospital
    • Cambs
      • Peterborough, Cambs, United Kingdom, PE3 9GZ
        • Peterborough City Hospital
    • Cleveland
      • Middlesbrough, Cleveland, United Kingdom, TS4 3BW
        • The James Cook University Hospital, Middlesbrough
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Dorchester, Dorset, United Kingdom, DT1 2JY
        • Dorset County Hospital
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
        • The University of Hull/Castle Hill Hospital
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Broomfield Hospital
      • Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
        • Southend University Hospital
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Hampshire Hospitals NHS Foundation Trust
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Blackpool Teaching Hospitals
      • Oldham, Lancashire, United Kingdom, OL1 2JH
        • The Pennine Acute Hospitals NHS Trust
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Northwick Park Hospital Harrow/ Royal Brompton Hospital London
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT16 1RH
        • South Eastern Health and Social Care
      • Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
        • Cardiovascular Research Unit, Craigavon Area Hospital
    • Notts
      • Nottingham, Notts, United Kingdom, NG5 1PB
        • Nottingham University Hospitals
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Royal Infirmary of Edinburgh
    • Strathclyde
      • Clydebank, Strathclyde, United Kingdom, G81 4DY
        • University of Glasgow
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Russells Hall Hospital
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
        • Pinderfields Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Vascular Biology and Hypertension Program
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Yuma Regional Medical Center
    • California
      • Beverly Hills, California, United States, 90211
        • Cedars Sinai Medical Center
      • Fresno, California, United States, 93721
        • UCSF - Fresno Community Regional Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Orange, California, United States, 92868
        • University Of California Irvine Medical Center
      • Palo Alto, California, United States, 94087
        • Palo Alto Medical Foundation Research Institute
      • Palo Alto, California, United States, 94550
        • VA Palo Alto Healthcare System
      • San Jose, California, United States, 94538
        • Kaiser Permanente San Jose
      • Santa Ana, California, United States, 92704
        • Coastal Heart Medical Group
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates, P.C.
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • Connecticut
      • West Haven, Connecticut, United States, 06111
        • VA Connecticut Healthcare System
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Daytona Heart Group
      • Gainesville, Florida, United States, 32608
        • Malcom Randall VAMC
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center of Sarasota
      • Tampa, Florida, United States, 33606
        • University Of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center
    • Illinois
      • Fairview Heights, Illinois, United States, 62208
        • Advanced Heart Care Group
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Krannert Institute of Cardiology
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Lexington, Kentucky, United States, 42503
        • Lexington VA Medical Center
      • Louisville, Kentucky, United States, 40292
        • University of Louisville
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Cardiovascular Specialists of Southwest Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
      • Bethesda, Maryland, United States, 20814
        • NIH Heart Center at Suburban Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital, Harvard Medical School
      • West Roxbury, Massachusetts, United States, 02132
        • VA Boston Healthcare System
      • Worcester, Massachusetts, United States, 01608
        • Saint Vincent Hospital at Worcester Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
      • Saginaw, Michigan, United States, 01876
        • Covenant Medical Center, Inc.
      • Southfield, Michigan, United States, 48075
        • Providence - Providence Park Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart, PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VAMC
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Paul, Minnesota, United States, 55102
        • HealthEast Saint Joseph's Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Pomona, New Jersey, United States, 08240
        • AtlantiCare Regional Medical Center
      • Saddle Brook, New Jersey, United States, 07663
        • Hackensack University Medical Center
    • New York
      • Albany, New York, United States, 12211
        • Capital Cardiology Associates
      • Albany, New York, United States, 12208
        • Albany Medical Center Hospital
      • Albany, New York, United States, 12208
        • Samuel Stratton VA Medical Center of Albany NY
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Bronx, New York, United States, 10451
        • NYU-HHC Lincoln Medical and Mental Health Center
      • Brooklyn, New York, United States, 11235
        • Coney Island Hospital
      • Brooklyn, New York, United States, 11203
        • NYU-HHC Kings County Hospital Center
      • Brooklyn, New York, United States, 11215
        • New York -Presbyterian/Brooklyn Methodist Hospital
      • Brooklyn, New York, United States, 11229
        • NYU-HHC Woodhull Hospital
      • Cortlandt Manor, New York, United States, 10567
        • NYP Medical Medical Group Hudson Valley Cardiology
      • Flushing, New York, United States, 11355
        • New York University - Langone Cardiovascular Associates
      • Kingston, New York, United States, 12401
        • Mid Valley Cardiology
      • Manhasset, New York, United States, 11030
        • Northwell Health - Manhasset
      • Mineola, New York, United States, 11501
        • NYU Winthrop
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10010
        • VA New York Harbor Health Care System
      • New York, New York, United States, 10016
        • Beth Israel Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Medical Center-Bellevue Hospital
      • New York, New York, United States, 10022
        • NYU New York Medical Associates
      • New York, New York, United States, 10025
        • Mount Sinai Saint Luke's Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Schenectady, New York, United States, 12309
        • Cardiology Associates of Schenectady P.C.
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology Associates
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Health
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati VA Medical Center
      • Cleveland, Ohio, United States, 44106
        • Louis Stokes Cleveland Veterans Affairs Medical Center
      • Columbus, Ohio, United States, 43215
        • Ohio Health Grant Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Oklahoma Heart Institute
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97225
        • Providence Heart and Vascular Institute
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18018
        • Saint Luke's Hospital and Health Network
      • Camp Hill, Pennsylvania, United States, 17011
        • Holy Spirit Hospital Cardiovascular Institute
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Health Cardiology
      • Johnstown, Pennsylvania, United States, 15905
        • Conemaugh Valley Memorial Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
      • Warwick, Rhode Island, United States, 02886
        • Kent Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 373203
        • Saint Thomas Hospital
    • Texas
      • Dallas, Texas, United States, 75216
        • V.A. North Texas Health Care System
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Baylor St. Luke's Medical Center
      • Houston, Texas, United States, 77339
        • Houston Heart & Vascular Associates
      • Plano, Texas, United States, 75024
        • Baylor Research Institute at Legacy Heart Center
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor
      • San Antonio, Texas, United States, 78229
        • Audie Murphy V.A.
      • Sugar Land, Texas, United States, 77478
        • Medicus Alliance Clinical Research Org., Inc.
      • Wichita Falls, Texas, United States, 76301
        • Wichita Falls Heart Clinic
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Salt Lake City VA Medical Center
    • Vermont
      • White River Junction, Vermont, United States, 05009
        • VAMC-White River Junction
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Cardiovascular Associates, Ltd.
      • Lynchburg, Virginia, United States, 24501
        • Stroobants Cardiovascular Center
      • Winchester, Virginia, United States, 22601
        • Winchester Cardiology and Vascular Medicine, PC
    • Washington
      • Bellevue, Washington, United States, 98004
        • University of Washington Medical Center
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least moderate ischemia on a qualifying stress test
  • Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
  • Participant is willing to give written informed consent
  • Age ≥ 21 years

Exclusion Criteria:

  • LVEF < 35%
  • History of unprotected left main stenosis >50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available)
  • Finding of "no obstructive CAD" (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months
  • Coronary anatomy unsuitable for either PCI or CABG
  • Unacceptable level of angina despite maximal medical therapy
  • Very dissatisfied with medical management of angina
  • History of noncompliance with medical therapy
  • Acute coronary syndrome within the previous 2 months
  • PCI within the previous 12 months
  • Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
  • History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause
  • NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
  • Non-ischemic dilated or hypertrophic cardiomyopathy
  • End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) <30mL/min (not an exclusion criterion for CKD ancillary trial, see CKD ancillary trial, Section 18)
  • Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
  • Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast
  • Planned major surgery necessitating interruption of dual antiplatelet therapy (note that patients may be eligible after planned surgery)
  • Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
  • Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
  • Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis (Those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core lab)
  • Enrolled in a competing trial that involves a non-approved cardiac drug or device
  • Inability to comply with the protocol
  • Exceeds the weight or size limit for CCTA or cardiac catheterization at the site
  • Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern
  • Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
  • High risk of bleeding which would contraindicate the use of dual antiplatelet therapy
  • Cardiac transplant recipient
  • Prior CABG, unless CABG was performed more than 12 months ago, and coronary anatomy has been demonstrated to be suitable for PCI or repeat CABG to accomplish complete revascularization of ischemic areas (CCC approval required)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Names:
  • Pharmacologic Therapy
Procedure: cardiac catheterization
Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
Other Names:
  • cath
Procedure: coronary artery bypass graft surgery
Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.
Other Names:
  • CABG
Procedure: percutaneous coronary intervention
Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
Other Names:
  • PCI
Behavioral: Lifestyle
diet, physical activity, smoking cessation
Other Names:
  • Behavior change
Active Comparator: Conservative Strategy
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Names:
  • Pharmacologic Therapy
Behavioral: Lifestyle
diet, physical activity, smoking cessation
Other Names:
  • Behavior change

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest
Time Frame: 3.2 year follow-up (median)
3.2 year follow-up (median)
Cumulative Event Rate of Primary Composite Outcome (Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest)
Time Frame: 5 years
This measure represents the estimated cumulative probability of experiencing the primary endpoint within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
5 years
Number of Participants That Experienced Death From Cardiovascular Causes or Myocardial Infarction
Time Frame: 5 years
5 years
Cumulative Event Rate of Death From Cardiovascular Causes or Myocardial Infarction
Time Frame: 5 years
This measure represents the estimated cumulative probability of experiencing Death from cardiovascular causes or myocardial infarction within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
5 years
Number of Participants That Experienced Death From Any Cause
Time Frame: 5 years
5 years
Cumulative Event Rate of Death From Any Cause
Time Frame: 5 years
5 years
Number of Participants That Experienced Myocardial Infarction
Time Frame: 5 years
5 years
Cumulative Event Rate of Myocardial Infarction
Time Frame: 5 years
5 years
Estimated Difference in Cumulative Event Rate ( %) of Primary Composite Outcome: Invasive Minus Conservative
Time Frame: 5 years
The primary composite outcome includes death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
5 years
Estimated Difference in Cumulative Event Rate of Death From Cardiovascular Causes: Invasive Minus Conservative or Myocardial Infarction Between Invasive and Conservative Strategies
Time Frame: 5 years
5 years
Estimated Difference in Cumulative Event Rate of Death From Any Cause: Invasive Minus Conservative
Time Frame: 5 years
5 years
Estimated Difference in Cumulative Event Rate of Myocardial Infarction: Invasive Minus Conservative
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Massachusetts General Hospital
University of British Columbia
National Heart, Lung, and Blood Institute (NHLBI)
New York University
Columbia University
Emory University
Duke University
Vanderbilt University
Stanford University
Cedars-Sinai Medical Center
Harvard University
Montreal Heart Institute
University of Missouri, Kansas City
East Carolina University
Albany Stratton VA Medical Center

Investigators

  • Study Chair: Judith S Hochman, MD, New York University
  • Principal Investigator: David J Maron, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimated)

November 15, 2011

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-00498
  • 1U01HL105907 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be submitted to the NHLBI according to their guidelines within 3 years after the final patient follow-up (June 30, 2019) or 2 years after the main paper of the trial has been published, whichever comes first.

IPD Sharing Time Frame

June 2022

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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