Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women)

Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grfating (SAG).

The specific aims of ROMA:Women are:

Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grfating (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time.

Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events.

Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups.

Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated.

Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG.

Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG.

Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Coronary Artery Disease; Coronary Artery Bypass Grafting
• Intervention / Treatment: Procedure: Single arterial graft; Procedure: Multiple arterial grafting

Detailed Description

ROMA:Women will leverage the infrastructure and the existing women population of the ROMA trial. ROMA:Women has two key Aims. In Aim 1, the investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). In Aim 2, the investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG. Differences by important subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated.

ROMA:Women is a two-arm, international, multi-center, randomized clinical trial nested in the ROMA trial. ROMA:Women will include all the women enrolled in the parent ROMA trial and will leverage the existing ROMA infrastructure including clinical trial unit, database, case report forms (CRF), randomization system, site training resources, informed consent forms (ICF), regulatory approvals, Central Events Review Committee (CEC) processes/personnel, network of participating sites, site PIs, and study coordinators. The planned randomization procedure, interventions and treatment arms, outcome assessments and follow-up protocol of ROMA:Women are identical to those of the currently ongoing parent ROMA trial. The sites participating in ROMA will continue enrollment of women after the completion of the ROMA trial and additional sites will also be opened to reach the target sample size of ROMA:Women.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Gaudino, Prof/PhD/MD; Phone Number: 212.746.1812; Email: mfg9004@med.cornell.edu
• Study Contact Backup: Name: Stephen Fremes, Prof/MD; Phone Number: 1 416 480 6073; Email: stephen.fremes@sunnybrook.ca

Study Locations

• Australia
  • Melbourne, Australia
    • Recruiting
    • The University of Melbourne
    • Contact: Alistair Royse, MD
• Austria
  • Graz, Austria, 8010
    • Recruiting
    • Medical University of Graz
    • Contact: Daniel Zimpfer, MD
  • Innsbruck, Austria, 6020
    • Recruiting
    • Innsbruck Medical University
    • Contact: Elfriede Ruttmann-Ulmer, MD
  • Linz, Austria
    • Recruiting
    • Kepler University Hospital
    • Contact: Andreas F Zierer, MD
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Sigrid Sandner, MD
  • Vienna, Austria, 1210
    • Recruiting
    • Krankenhaus Nord Vienna North Hospital
    • Contact: Berhard Winkler, MD
• Brazil
  • Porto Alegre, Brazil, 9062000
    • Not yet recruiting
    • Institute of Cardiology Porto Alegre
    • Contact: Renato Kalil, MD
  • São Paulo, Brazil, 05508
    • Not yet recruiting
    • Heart Institute University of São Paulo
    • Contact: Fabio B Jatene, MD
  • Vila Mariana, Brazil, 04012-909
    • Not yet recruiting
    • Instituto Dante Pazzanese de Cardiologia
    • Contact: Renato T Arnoni, MD
• Canada
  • Montréal, Canada
    • Recruiting
    • Hopital Sacre-Coeur
    • Contact: Hugues Jeanmart, MD
  • New Westminster, Canada
    • Recruiting
    • Fraser Clinical Trials
    • Contact: Daniel Wong, MD
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Recruiting
      • St. Boniface General Hospital
      • Contact: Rakesh Arora, MD
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Recruiting
      • Horizon Health Network - Saint John Regional Hospital
      • Contact: Craig Brown, MD
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton General Hospital
      • Contact: Andre Lamy, MD
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • London Health Sciences
      • Contact: David Nagpal, MD
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Marc Ruel, MD
    • Sudbury, Ontario, Canada, P3E 5J1
      • Not yet recruiting
      • Health Sciences North
      • Contact: Bindu Bittira, MD
    • Toronto, Ontario, Canada, M5G 2C4
      • Not yet recruiting
      • Toronto General Hospital
      • Contact: Vivek Rao, MD
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences
      • Contact: Stephen E Fremes, MD
  • Quebec
    • Montréal, Quebec, Canada, H1T 1C8
      • Recruiting
      • Montreal Heart Institute
      • Contact: Philippe Demers, MD
    • Montréal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Royal Victoria Hospital
      • Contact: Kevin Lachapelle, MD
    • Montréal, Quebec, Canada, H2X 3E4
      • Recruiting
      • University Hospital of Montreal
      • Contact: Nicolas Noiseux, MD
    • Ste Foy, Quebec, Canada, G1V 4G5
      • Recruiting
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
      • Contact: Pierre Voisine, MD
• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Not yet recruiting
      • Fuwai Hospital China
      • Contact: Zhe Zheng, MD
  • Jilin
    • Changchun, Jilin, China, 130052
      • Recruiting
      • Jilin Heart Hospital China
      • Contact: Massimo Lemma, MD
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
      • Contact: Qiang Zhao, MD
  • Tianjin
    • Tianjin, Tianjin, China, 300456
      • Not yet recruiting
      • Teda Hospital Tianjin China
      • Contact: Guo-Wei He, MD
• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • University Hospital Dubrava
    • Contact: Igor Rudez, MD
• Czechia
  • Hradec Králové, Czechia, 500 03
    • Not yet recruiting
    • University Hradec Králové
    • Contact: Jan Vojacek, MD
  • Nové Město, Czechia, 128 08
    • Not yet recruiting
    • General University Hospital, Prague
    • Contact: Tomas Prskavec, MD
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Not yet recruiting
    • HDZ NRW Bad Oeynhausen Germany
    • Contact: Marcus-Andre Deutsch, MD
  • Berlin, Germany
    • Recruiting
    • Deutsches Herzzentrum der Charité
    • Contact: Stephan Jacobs
  • Duisburg, Germany, 47057
    • Not yet recruiting
    • Essen University
    • Contact: Mathias Thielmann, MD
  • Duisburg, Germany, 47137
    • Not yet recruiting
    • Duisburg Heart Center
    • Contact: Jochen Börgermann, MD
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Dusseldorf University
    • Contact: Alexander Assmann, MD
  • Erlangen, Germany, 91054
    • Not yet recruiting
    • University Hospital Erlangen
    • Contact: Ehab Nooh, MD
  • Frankfurt, Germany, 60323
    • Not yet recruiting
    • Frankfurt University
    • Contact: Thomas Holubec, MD
  • Gießen, Germany, 35385
    • Recruiting
    • University Hospital of Giessen and Marburg
    • Contact: Andreas Boening, MD
  • Göttingen, Germany, 37075
    • Not yet recruiting
    • University Medical Center of Göttingen
    • Contact: Bernd Danner, MD
  • Jena, Germany, 07743
    • Recruiting
    • Jena University Hospital
    • Contact: Torsten Doenst, MD
  • Leipzig, Germany, 04289
    • Recruiting
    • Heart Center Herzzentrum, Leipzig
    • Contact: Michael Borger, MD
  • Stuttgart, Germany, 70376
    • Not yet recruiting
    • Robert-Bosch-Hospital Stuttgart Germany
    • Contact: Marc Albert, MD
  • Trier, Germany, 54292
    • Recruiting
    • Krankenhaus der Barmherzigen Brüder Trier
    • Contact: John D Terrence, MD
  • Baden-Wuerttemberg
    • Bad Krozingen, Baden-Wuerttemberg, Germany, 79189
      • Not yet recruiting
      • Universitäts-Herzzentrum Bad Krozingen Freiburg
      • Contact: Martin Czerny, MD
• India
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641037
      • Recruiting
      • G Kuppuswamy Naidu Memorial Hospital (GKNM)
      • Contact: Chandra Padmanabhan, MD
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Recruiting
      • Star Hospitals - Hyderabad, India
      • Contact: Gopichand Mannam, MD
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
    • Contact: Gil Bolotin, MD
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Anthea Hospital
    • Contact: Giuseppe Speziale, MD
  • Brescia, Italy, 25124
    • Not yet recruiting
    • Fondazione Poliambulanza
    • Contact: Gianni Troise, MD
  • Cotignola, Italy, 48033
    • Not yet recruiting
    • Maria Cecilia Hospital GVM
    • Contact: Alberto Albertini, MD
  • Roma, Italy, 00149
    • Recruiting
    • European Hospital
    • Contact: Ruggero De Paulis, MD
  • Roma, Italy, 00168
    • Recruiting
    • Universita' Cattolica del Sacro Cuore
    • Contact: Massimo Massetti, MD
  • Torino, Italy, 10126
    • Not yet recruiting
    • Ospedale Le Molinette, Torino
    • Contact: Mauro Rinaldi, MD
• Japan
  • Saitama, Japan, 350-0451
    • Not yet recruiting
    • Saitama Medical University Japan
    • Contact: Hiroyuki Nakajima, MD
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan, 113-8510
      • Not yet recruiting
      • Tokyo Medical and Dental University
      • Contact: Hirokuni Arai, MD
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ho Younh Hwang, MD
  • Seúl, Korea, Republic of, 03722
    • Not yet recruiting
    • Severance Cardiovascular Hospital, Yonsei University College of Medicine
    • Contact: Kyung-Jong Yoo, MD
• Netherlands
  • Maastricht, Netherlands, 6229
    • Recruiting
    • Maastricht University Medical Centre
    • Contact: Roberto Lorusso, MD
• North Macedonia
  • Skopje, North Macedonia
    • Recruiting
    • Acibadem-Sistina Hospital
    • Contact: Aleksandar Nikolikj, MD
• Poland
  • Katowice, Poland, 40-055
    • Recruiting
    • Medical University of Silesia
    • Contact: Marek Deja, MD
  • Zabrze, Poland, 41-800
    • Recruiting
    • Zbigniew Religa Lower Silesian Heart Disease Centre
    • Contact: Romuald Cichon, MD
• Portugal
  • Coimbra, Portugal, 3004-561
    • Recruiting
    • University Hospital Coimbra
    • Contact: Manuel Antunes, MD
  • Lisboa, Portugal, 1300-598
    • Not yet recruiting
    • Centro Hospitalar Lisboa Ocidental
    • Contact: Miguel Sousa Uva, MD
  • Porto, Portugal, 4200-319
    • Not yet recruiting
    • Centro Hospitalar e Universitário Sao João
    • Contact: Adelino Leite-Moreira, MD
• Russian Federation
  • Tomsk, Russian Federation
    • Recruiting
    • National Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia
    • Contact: Yuri Vechersky, MD
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Dedinje Cardiovascular Institute
    • Contact: Milan Milojevic, MD
• Singapore
  • Singapore, Singapore, 119077
    • Not yet recruiting
    • National University of Singapore
    • Contact: Theodoros Kofidis, MD
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic de Barcelona
    • Contact: Jorge Alcocer, MD
  • Madrid, Spain
    • Recruiting
    • Hospital Clinico de San Carlos
    • Contact: Paula Campelos, MD
  • Pamplona, Spain
    • Recruiting
    • NavarraBiomed
    • Contact: Javier De Diego Candela, MD
  • Alicante
    • Elx, Alicante, Spain, 03293
      • Recruiting
      • Hospital Universitario del Vinalopó
      • Contact: Jose Albors Martin, MD
• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Anders Jeppsson, MD
• Taiwan
  • Taipei
    • Zhongzheng, Taipei, Taiwan, 100229
      • Not yet recruiting
      • National Taiwan University Hospital
      • Contact: Yih-Sharng Chen, MD
• United Kingdom
  • Hull, United Kingdom
    • Recruiting
    • Hull University Hospitals
    • Contact: Mahmoud Loubani, MD
  • Leicester, United Kingdom
    • Recruiting
    • University Hospitals of Leicester
    • Contact: Mustafa Zakkar, MD
  • London, United Kingdom
    • Recruiting
    • St George's University Hospitals
    • Contact: Marjan Jahangiri, MD
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Joanna Chikwe, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Jessica Rove, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University Hospital
      • Contact: Roland Assi, MD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Hasam Balkhy, MD
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Johns Hopkins University
      • Contact: Jennifer Lawton, MD
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Recruiting
      • Baystate Health
      • Contact: Daniel Engelman, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St. Louis
      • Contact: Puja Kachroo, MD
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Not yet recruiting
      • Nebraska Heart Hospital
      • Contact: Omar Nass
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Aleem Siddique, MD
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Recruiting
      • Englewood Health
      • Contact: Molly Schultheis, MD
    • Newark, New Jersey, United States, 07112
      • Recruiting
      • Newark Beth Israel Medical Center
      • Contact: Arash Salemi, MD
    • Ridgewood, New Jersey, United States, 07450
      • Recruiting
      • The Valley Hospital
      • Contact: Juan B Grau, MD
  • New York
    • Brooklyn, New York, United States, 11215
      • Recruiting
      • NewYork-Presbyterian Brooklyn Methodist Hospital
      • Contact: Sandhya Balaram, MD
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Mario Gaudino, Prof/PhD/MD; Phone Number: 212-746-1812; Email: mfg9004@med.cornell.edu
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Contact: Koji Takeda, MD
    • New York, New York, United States, 10075
      • Not yet recruiting
      • Lenox Hill Hospital
      • Contact: Nirav Patel, MD
    • New York, New York, United States, 10029
      • Not yet recruiting
      • Icahn School of Medicine, Mount Sinai
      • Contact: John Puskas, MD
    • Queens, New York, United States, 11355
      • Recruiting
      • New York Presbyterian Queens
      • Contact: Charles Mack, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Brittany Zwischenberger, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
      • Cleveland Clinic Foundation
      • Contact: Faisal Bakaeen, MD
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: Jovan Bozinovski, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Marisa Cevasco, MD
    • Pittsburgh, Pennsylvania, United States, 15212
      • Not yet recruiting
      • Allegheny General Hospital
      • Contact: Scott Halbreiner, MD
    • Wynnewood, Pennsylvania, United States, 19096
      • Recruiting
      • Lankenau Medical Center
      • Contact: Gianluca Torregrossa, MD
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: Afshin Efsan, MD
  • Texas
    • Dallas, Texas, United States, 75204
      • Recruiting
      • Baylor Scott & White Research Institute
      • Contact: Michael DiMaio, MD
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
      • Contact: Sara Pereira, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women patients ≥18 years old.
2. Isolated coronary artery bypass grafting.
3. Primary (first time) cardiac surgery procedure.
4. Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

Exclusion Criteria:

• Male gender
• Single graft
• Emergency operation
• Myocardial infarction within 72 hours of surgery
• Left ventricular ejection fraction < 35%
• Any concomitant cardiac or non-cardiac procedure
• Previous cardiac surgery
• Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.
• Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
• Anticipated need for coronary thrombo-endarterectomy
• Planned hybrid revascularization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arterial Graft (SAG) group; Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.	Procedure: Single arterial graft; This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
Experimental: Multiple Arterial Graft (MAG) group; Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.	Procedure: Multiple arterial grafting; This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.	The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.	Postoperatively, minimum 2.5 year follow-up
Primary outcome for aim 2: Disease-specific quality of life	Assessed using the Seattle Angina Questionnaire (SAQ), a validated 19-item questionnaire that measures five domains related to coronary disease: angina frequency, physical limitations, quality of life, angina stability, and treatment satisfaction. Scores range from 0 to 100 with higher scores indicating fewer symptoms and better health status. The minimum clinically important difference on the SAQ is 5 points. The primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline.	Postoperatively, minimum 2.5 year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.	One of the secondary outcomes for aim 1: It will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (>48 hours after surgery), and repeat revascularization. This is the primary outcome of the parent ROMA trial.	Postoperatively, minimum 2.5 year follow-up
Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.	Another secondary outcome for aim 1: It will be a composite of the first occurrence of death from cardiac cause, any stroke, non-procedural myocardial infarction (>48 hours after surgery), repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure.	Postoperatively, minimum 2.5 year follow-up
Death from any cause	Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified.	Postoperatively, minimum 2.5 year follow-up
Stroke	Another secondary outcome for aim 1: Based on the American Heart Association/American Stroke Association Expert Consensus stroke definition, stroke will be identified in case of: pathological, imaging, or other objective evidence of cerebral ischemic injury in a defined vascular distribution; OR; clinical evidence of cerebral ischemic injury based on symptoms persisting ≥24 hours or until death, and other etiologies excluded.	Postoperatively, minimum 2.5 year follow-up
Non-procedural myocardial infarction	Another secondary outcome for aim 1: Based on the 4th Universal Definition, non-periprocedural myocardial infarction will be identified in case of detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia; electrocardiogram changes indicative of new ischemia (new ST-T changes or new left bundle branch block); development of pathological Q waves in the electrocardiogram; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.	> 48 hours postoperatively, minimum 2.5 year follow-up
Repeat revascularization	Another secondary outcome for aim 1: Repeat revascularization will include any percutaneous or surgical revascularization on a grafted coronary artery after the initial operation.	Postoperatively, minimum 2.5 year follow-up
Readmission for acute coronary syndrome	Another secondary outcome for aim 1: Prolonged ischemic symptoms at rest (usually ≥10 minutes in duration), or accelerating pattern of chest pain that occurs with a lower activity threshold (CCS class III or IV) considered to be myocardial ischemia upon final diagnosis resulting in an unscheduled visit to a healthcare facility resulting in an overnight stay generally within 24 hours of the most recent symptoms, cardiac biomarkers not meeting MI criteria, and ECG or angiographic evidence of ischemia.	Postoperatively, minimum 2.5 year follow-up
Readmission for heart failure	Another secondary outcome for aim 1: While patients may have multiple simultaneous disease processes, for the outcome event of heart failure requiring hospitalization, the diagnosis of congestive heart failure would need to be the primary process. Heart failure (HF) requiring hospitalization is defined as an event that meets the following criteria: i. Requires hospitalization AND ii. Clinical symptoms of heart failure AND iii. Physical signs of heart failure AND iv. Need for additional/increased therapy AND v. No other non-cardiac etiology (such as chronic obstructive pulmonary disease, hepatic cirrhosis, acute renal failure, or venous insufficiency) and no other cardiac etiology (such as pulmonary embolus, cor pulmonale, primary pulmonary hypertension, or congenital heart disease) for signs or symptoms are identified.	Postoperatively, minimum 2.5 year follow-up
Generic quality of life according to the Short Form Health Survey (SF-12v2)	Secondary outcomes for aim 2: The SF-12v12 measures eight dimensions of health: physical functioning, role limitations due to physical problems, bodily pain, vitality, general health perception, social function, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100 with higher scores indicating better health status. The SF-12v2 has two summary measures: physical and mental self-perceived health with norm-based methods that standardize the score to a mean of 50 and standard deviation of 10.	Postoperatively, minimum 2.5 year follow-up
Generic quality of life according to EuroQuol-5D (EQ-5D)	Secondary outcomes for aim 2: EQ-5D is a five-item instrument to assess health status in the following five dimensions: mobility, self-care, usual activity, pain or discomfort, and anxiety or depression. Individual domain scores will be converted to a summary index representing utility weights, which allow conduct of cost-effectiveness analyses.	Postoperatively, minimum 2.5 year follow-up
Mental and physical health symptoms according to PROMIS instruments	Secondary outcomes for aim 2: Physical and mental health symptoms and physical functioning will be measured with standardized PROMIS instruments, including: Pain interference, Neuropathic Pain, Fatigue, Sleep disturbance, Depression, Anxiety, and Physical Function. A mean of 50 and a standard deviation of 10 represent the general population in the US.	Postoperatively, minimum 2.5 year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other recorded outcomes (safety endpoints)	30-day mortality and major postoperative complications (revision for bleeding, perioperative MI (<48 hours after surgery), need for dialysis, need for tracheostomy, and surgical site complications).	Within 30 days of surgery or during index hospitalization, whichever is longer.

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Sunnybrook Health Sciences Centre; Columbia University; Duke University; Cedars-Sinai Medical Center; New York Presbyterian Hospital
• Investigators: Principal Investigator: Mario Gaudino, Prof/PhD/MD, Weill Medical College of Cornell University; Principal Investigator: Ruth Masterson Creber, RN, PhD, Columbia University; Principal Investigator: C. Noel Bairey Merz, MD, Cedars-Sinai; Principal Investigator: Karla Ballman, PhD, Weill Medical College of Cornell University; Principal Investigator: Sean O'Brien, PhD, Duke University; Principal Investigator: Stephen Fremes, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

General Publications

• Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.
• Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6.
• Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X.
• Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X.
• Yi G, Shine B, Rehman SM, Altman DG, Taggart DP. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014 Aug 12;130(7):539-45. doi: 10.1161/CIRCULATIONAHA.113.004255. Epub 2014 Jun 10.
• Aldea GS, Bakaeen FG, Pal J, Fremes S, Head SJ, Sabik J, Rosengart T, Kappetein AP, Thourani VH, Firestone S, Mitchell JD; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Feb;101(2):801-9. doi: 10.1016/j.athoracsur.2015.09.100. Epub 2015 Dec 8.
• Benedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg. 2015 Jan;47(1):59-65; discussion 65. doi: 10.1093/ejcts/ezu111. Epub 2014 Mar 30.
• Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.
• Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease
• Other Study ID Numbers: 1703018094-ROMA-Women

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Primary outcome data under request
• IPD Sharing Time Frame: From publication until the third year after publication
• IPD Sharing Access Criteria: Research scope
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No