Clinical trial NCT01443637: COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM)
Official title: COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Coronary Artery Disease
Cardiovascular Disease
Keywords: Coronary Artery Disease
CAD
Atherosclerosis
Myocardial Infarction
MI
CONFIRM
Coronary Computed Tomographic Angiography
CCTA
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 34000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consist of patients at multiple international centers undergoing clinically-indicated coronary CT angiography as part of their standard of care.

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.

Eligibility criteria: 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.

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.

Exclusion Criteria:

No explicit patient exclusion criteria are defined.

Primary outcomes:
measure: Coronary and non-coronary cardiac findings by CCTA
timeFrame: yearly
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Cardiovascular Medical Group of Southern California
state: California
city: Los Angeles
country: United States
facility: Harbor UCLA
state: California
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Hendersonville
country: United States
facility: Tenessee Heart and Vascular Institute
state: Tennessee
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Vancouver
country: Canada
facility: Providence Health Care
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Giessen
country: Germany
facility: University of Giessen
city: Munich
country: Germany
facility: Deutsches Herzzentrum Munchen
city: Parma
country: Italy
facility: University of Parma
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: Weill Medical College of Cornell University
name: Leslee J Shaw, PhD
role: PRINCIPAL_INVESTIGATOR
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