Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry (CONFIRM2)

June 3, 2026 updated by: Cleerly, Inc.

Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter

The overall objective of CONFIRM2 is to perform the largest cardiovascular phenotype outcomes study ever.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

CONFIRM2 is a retrospective and prospective, open-label, international, multicenter observational registry designed to evaluate associations between CCTA imaging findings and clinical presentation (cross-sectional) and their ability to predict mortality and major adverse cardiac events (longitudinal) in patients with chronic CAD.

Study Type

Observational

Enrollment (Estimated)

15000

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

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • University of Virginia

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

Sampling Method

Probability Sample

Study Population

Patients with stable coronary artery disease

Description

Inclusion Criteria:

  • Age >18 years
  • Undergoing clinically indicated CCTA with >64-detector row CT
  • Signed informed consent, including of release of medical information, long term follow-up and Health Insurance Portability and Accountability Act (HIPAA) documentation

Exclusion Criteria:

  • Individuals unable to provide informed consent
  • Non-cardiac illness with life expectancy < 2 years
  • Pregnancy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary CT Angiography EvaluatioN For Clinical Outcomes
Time Frame: June 2020- June 2022
Examined the totality of information visualized by coronary CT angiography (CCTA) for optimal refinement of prognostic risk stratification
June 2020- June 2022

Collaborators and Investigators

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

Sponsor

Cleerly, Inc.

Investigators

  • Study Chair: James K Min, MD, Cleerly, Inc.
  • Study Chair: Udo Hoffmann, MD, Cleerly, Inc.

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, 2020

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Confirm2-Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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