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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01443637
Recruitment Status : Enrolling by invitation
First Posted : September 30, 2011
Last Update Posted : January 4, 2019
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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
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.

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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry
Actual Study Start Date : June 2003
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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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
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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01443637

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Cardiovascular Medical Group of Southern California
Los Angeles, California, United States, 90210
Harbor UCLA
Los Angeles, California, United States, 90502
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20889
United States, Florida
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New York
Capital Cardiology Associates
Albany, New York, United States, 12208
Weill Cornell Medical Center
New York, New York, United States, 10021
United States, Tennessee
Tenessee Heart and Vascular Institute
Hendersonville, Tennessee, United States, 37035
Medical University Innsbruck
Innsbruck, Austria
Canada, British Columbia
Providence Health Care
Vancouver, British Columbia, Canada
Canada, Ontario
Ottawa Heart Institute
Ottawa, Ontario, Canada
University of Giessen
Giessen, Germany
Deutsches Herzzentrum Munchen
Munich, Germany
University of Parma
Parma, Italy
Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of
Severance Cardiovascular Hospital
Seoul, Korea, Republic of
University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
Weill Medical College of Cornell University
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Principal Investigator: James K Min, MD Cedars-Sinai Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Weill Medical College of Cornell University Identifier: NCT01443637     History of Changes
Other Study ID Numbers: 1310014468
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Weill Medical College of Cornell University:
Coronary Artery Disease
Myocardial Infarction
Coronary Computed Tomographic Angiography
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases