COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM)

NCT ID: NCT01443637

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2016-03-01

Brief Summary

The CONFIRM study was developed to examine the prognostic value of cardiac computed tomographic angiography (CCTA) findings for prediction of future adverse cardiac events related to coronary artery disease (CAD) in a large, international patient population. The purpose of this multicenter registry is to correlate coronary and non-coronary cardiac findings by CCTA with demographic and clinical data for refinement of risk stratification of individuals with suspected or known CAD.

Detailed Description

Coronary computed tomographic angiography (CCTA) of 64-detector rows or greater represents a novel noninvasive anatomic method for evaluation of patients with suspected coronary artery disease (CAD). Early studies suggest a potential for prognostic risk assessment by CCTA findings but were limited by small patient cohorts or single centers. The CONFIRM Registry is a large, prospective, multinational dynamic observational study of patients undergoing CCTA. The primary aim of CONFIRM is to determine the prognostic value of CCTA findings for the prediction of future adverse CAD events.

The CONFIRM registry currently represents 27,125 consecutive patients at 12 cluster sites in 6 countries in North America, Europe, and Asia. CONFIRM sites were chosen on the basis of adequate CCTA volume, site CCTA proficiency, and local demographic characteristics and medical facilities to ensure a broad-based sample of patients. Patients comprising the present CONFIRM cohort include those with suspected but without known CAD, with known CAD, or asymptomatic persons undergoing CAD evaluation. A data dictionary comprising a wide array of demographic, clinical, and CCTA findings was developed by the CONFIRM investigators and is uniformly used for all patients. Patients are followed up after CCTA performance to identify adverse CAD events, including death, myocardial infarction, unstable angina, target vessel revascularization, and CAD-related hospitalization.

Conditions

Atherosclerosis; Coronary Artery Disease; Cardiovascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Coronary CT Angiography (CCTA)

Patients included in the CONFIRM Registry are those that have previously undergone clinically-indicated CCTA as part of their standard of care.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years

2. Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of standard of care

3. Interpretable CCTA

4. Prospective data collection for CAD risk factors.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslee J Shaw, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Cardiovascular Medical Group of Southern California

Los Angeles, California, United States

Harbor UCLA

Los Angeles, California, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Henry Ford Hospital

Detroit, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Capital Cardiology Associates

Albany, New York, United States

Weill Cornell Medical Center

New York, New York, United States

Tenessee Heart and Vascular Institute

Hendersonville, Tennessee, United States

Medical University Innsbruck

Innsbruck, , Austria

Providence Health Care

Vancouver, British Columbia, Canada

Ottawa Heart Institute

Ottawa, Ontario, Canada

University of Giessen

Giessen, , Germany

Deutsches Herzzentrum Munchen

Munich, , Germany

University of Parma

Parma, , Italy

Seoul National University College of Medicine

Seoul, , South Korea

Severance Cardiovascular Hospital

Seoul, , South Korea

University Hospital of Zurich

Zurich, , Switzerland

Countries

United States; Austria; Canada; Germany; Italy; South Korea; Switzerland

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Other Identifiers

1310014468

Identifier Type: -

Identifier Source: org_study_id