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

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Age > 18 years
Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of standard of care
Interpretable CCTA
Prospective data collection for CAD risk factors.

Exclusion Criteria

No explicit patient exclusion criteria are defined.

Primary Outcome Measures

Name	Time	Method
Coronary and non-coronary cardiac findings by CCTA	yearly	Identify, quantify, and integrate coronary and noncoronary cardiac findings by Coronary computed tomographic angiography (CCTA) with demographic and clinical data for refinement of risk stratification of persons with suspected or known CAD.

Secondary Outcome Measures

Name	Time	Method

Locations (20): Capital Cardiology Associates
🇺🇸
Albany, New York, United States
Deutsches Herzzentrum Munchen
🇩🇪
Munich, Germany
Medical University Innsbruck
🇦🇹
Innsbruck, Austria
Seoul National University College of Medicine
🇰🇷
Seoul, Korea, Republic of
University Hospital of Zurich
🇨🇭
Zurich, Switzerland
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
Emory University
🇺🇸
Atlanta, Georgia, United States
Weill Cornell Medical Center
🇺🇸
New York, New York, United States
Baptist Cardiac and Vascular Institute
🇺🇸
Miami, Florida, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
University of Giessen
🇩🇪
Giessen, Germany
University of Parma
🇮🇹
Parma, Italy
Walter Reed Army Medical Center
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Washington, District of Columbia, United States
Ottawa Heart Institute
🇨🇦
Ottawa, Ontario, Canada
Tenessee Heart and Vascular Institute
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Hendersonville, Tennessee, United States
Severance Cardiovascular Hospital
🇰🇷
Seoul, Korea, Republic of
Providence Health Care
🇨🇦
Vancouver, British Columbia, Canada