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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT01443637

Collaborator

(none)

34,000

Enrollment

Locations

153

Actual Duration (Months)

1700

Patients Per Site

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Coronary Artery Disease Cardiovascular Disease

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.

Study Design

Study Type:

Observational

Actual Enrollment :

34000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry

Actual Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	Cardiovascular Medical Group of Southern California	Los Angeles	California	United States	90210
3	Harbor UCLA	Los Angeles	California	United States	90502
4	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20889
5	Baptist Cardiac and Vascular Institute	Miami	Florida	United States	33176
6	Emory University	Atlanta	Georgia	United States	30322
7	Henry Ford Hospital	Detroit	Michigan	United States	48202
8	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
9	Capital Cardiology Associates	Albany	New York	United States	12208
10	Weill Cornell Medical Center	New York	New York	United States	10021
11	Tenessee Heart and Vascular Institute	Hendersonville	Tennessee	United States	37035
12	Medical University Innsbruck	Innsbruck		Austria
13	Providence Health Care	Vancouver	British Columbia	Canada
14	Ottawa Heart Institute	Ottawa	Ontario	Canada
15	University of Giessen	Giessen		Germany
16	Deutsches Herzzentrum Munchen	Munich		Germany
17	University of Parma	Parma		Italy
18	Seoul National University College of Medicine	Seoul		Korea, Republic of
19	Severance Cardiovascular Hospital	Seoul		Korea, Republic of
20	University Hospital of Zurich	Zurich		Switzerland