COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM) (CONFIRM)
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|ClinicalTrials.gov Identifier: NCT01443637|
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : January 13, 2022
|Condition or disease|
|Atherosclerosis Coronary Artery Disease Cardiovascular Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||34000 participants|
|Official Title:||COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry|
|Actual Study Start Date :||June 2003|
|Actual Primary Completion Date :||March 1, 2016|
|Actual Study Completion Date :||March 1, 2016|
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.
- Coronary and non-coronary cardiac findings by CCTA [ Time Frame: 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443637
|Principal Investigator:||Leslee J Shaw, PhD||Weill Medical College of Cornell University|