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

January 12, 2022 updated by: Weill Medical College of Cornell University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

34000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
yearly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2003

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (ESTIMATE)

September 30, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1310014468

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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