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

NCT ID: NCT04279496

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 35000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2027-06-01

Brief Summary

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

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cleerly, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James K Min, MD

Role: STUDY_CHAIR

Cleerly, Inc.

Todd Villines, MD

Role: STUDY_CHAIR

UVA

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

Feuchtner GM, Lacaita PG, Bax JJ, Rodriguez F, Nakanishi R, Pontone G, Mushtaq S, Buechel RR, Grani C, Patel AR, Singulane CC, Choi AD, Al-Mallah M, Andreini D, Karlsberg RP, Cho G, Rochitte CE, Alasnag M, Hamdan A, Cademartiri F, Maffei E, Marques H, Goncalves Pereira PM, Gupta H, Hadamitzky M, Khalique O, Kalra D, Mills JD, Nurmohamed NS, Knaapen P, Budoff M, Shaikh K, Martin E, German DM, Ferencik M, Oehler AC, Deano R, Nagpal P, Van Assen M, De Cecco CN, Foldyna B, Brendel JM, Cheng VY, Branch K, Bittencourt M, Bhatti S, Polsani V, Wesbey G, Cardoso R, Blankstein R, Delago A, Pursnani A, Alsaid A, Bloom S, Kamperidis V, Barbieri F, Aquino M, Danad I, van Rosendael A. AI-Quantitative CT Coronary Plaque Features Associate With a Higher Relative Risk in Women: CONFIRM2 Registry. Circ Cardiovasc Imaging. 2025 Jun;18(6):e018235. doi: 10.1161/CIRCIMAGING.125.018235. Epub 2025 Mar 31.

Reference Type: DERIVED

PMID: 40162910 (View on PubMed)

Other Identifiers

Confirm2-Registry

Identifier Type: -

Identifier Source: org_study_id