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
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|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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
All consecutive patients at cluster sites meeting all inclusion criteria undergoing CCTA of 64-detector rows or greater will be included within the CONFIRM registry.
- 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.
No explicit patient exclusion criteria are defined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Weill Medical College of Cornell University|
|Other Study ID Numbers:||
|First Posted:||September 30, 2011 Key Record Dates|
|Last Update Posted:||January 13, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Coronary Artery Disease
Coronary Computed Tomographic Angiography
Coronary Artery Disease
Arterial Occlusive Diseases