Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE)

Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life

To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Cardiac CT; Procedure: Invasive Coronary Angiography

Detailed Description

A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.

• Study Type: Interventional
• Enrollment (Actual): 1631
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Curitiba, Brazil
    • Quanta Diagnostico Nuclear, Curitiba-PR
• India
  • Hyderabad, India
    • FACTS
• Italy
  • Monzino, Italy
    • Centro Cardiologico Monzino
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Ajou University Hospital
  • Seoul, Korea, Republic of
    • Gangneung Asan Hospital
  • Seoul, Korea, Republic of
    • Korea University, Guro hospital
  • Seoul, Korea, Republic of
    • Pusan National University Hospital
  • Seoul, Korea, Republic of
    • Yeongnam University Hospital
  • South Korea
    • Seoul, South Korea, Korea, Republic of
      • KangWon National University Hospital
• Poland
  • Warsaw, Poland
    • Institute of Cardiology Warsaw
• United States
  • Maryland
    • Bethesda, Maryland, United States
      • Walter Reed Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

1. Age >18 years
2. Patients providing written informed consent
3. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication

EXCLUSION CRITERIA

1. Known CAD (myocardial infarction, PCI, CABG)
2. ACC/AHA Class I or III indication for ICA
3. Non-cardiac illness with life expectancy <2 years
4. Inability to provide written informed consent
5. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
6. Pregnant women
7. Allergy to iodinated contrast agent
8. Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min
9. Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
10. Heart rate ≥100 beats per minute

12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cardiac CT; Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)	Procedure: Cardiac CT; Perform a non-invasive Cardiac CT Angiogram
Active Comparator: Invasive Coronary Angiography; Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography	Procedure: Invasive Coronary Angiography; Patient undergoes Invasive Coronary Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE Endpoints	Death; Non-fatal myocardial infarction; Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive); Stroke; Urgent or emergent coronary revascularization; Cardiovascular hospitalization (including for angina, heart failure or other)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional MACE Endpoints	The primary composite MACE endpoint plus major bleeding.; The primary composite MACE endpoint plus major bleeding or need for urgent/ emergent surgery due to hemorrhage.; The primary composite MACE endpoint plus major bleeding plus need for urgent/ emergent surgery due to hemorrhage plus need for major transfusion.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic	The secondary economic endpoint is within-trial cardiovascular costs*. *Costs will include index- and downstream CAD-related costs related to diagnostic testing, medications, hospitalizations, emergency department visits, outpatient visits, and coronary revascularizations. (Costs will also include non-CAD-related but test related costs.)	1 year
Secondary Safety Endpoint	The secondary safety endpoint will be rates of serious test-related complications*. *Serious test-related complications will include contrast-induced nephropathy, hematoma requiring transfusion, arteriovenous fistula, aneurysm formation, retroperitoneal bleed, arterial dissection and any surgery for test-related complications and cumulative CAD test-related effective biological radiation dose.	1 year
Quality of Life	The tertiary endpoint will be general and angina-specific quality of life, as measured by the EQ-5D Health Survey and Seattle Angina Questionnaire, respectively.	1 year

Collaborators and Investigators

• Sponsor: MDDX LLC
• Collaborators: GE Healthcare
• Investigators: Study Director: Dan Gebow, PhD, MDDX LLC; Principal Investigator: James Min, MD, Cornell Weill Medical College; Principal Investigator: Hyuk-Jae Chang, MD, Severance Hospital

Publications and helpful links

General Publications

• Chang HJ, Lin FY, Gebow D, An HY, Andreini D, Bathina R, Baggiano A, Beltrama V, Cerci R, Choi EY, Choi JH, Choi SY, Chung N, Cole J, Doh JH, Ha SJ, Her AY, Kepka C, Kim JY, Kim JW, Kim SW, Kim W, Pontone G, Valeti U, Villines TC, Lu Y, Kumar A, Cho I, Danad I, Han D, Heo R, Lee SE, Lee JH, Park HB, Sung JM, Leflang D, Zullo J, Shaw LJ, Min JK. Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1303-1312. doi: 10.1016/j.jcmg.2018.09.018. Epub 2018 Dec 12.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Cardiac CT; Catheterization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CONSERVE