Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry
CONFIRM2
1 other identifier
observational
35,000
1 country
1
Brief Summary
The overall objective of CONFIRM2 is to perform the largest cardiovascular phenotype outcomes study ever.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
November 26, 2024
November 1, 2024
7 years
February 19, 2020
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Coronary CT Angiography EvaluatioN For Clinical Outcomes
Examined the totality of information visualized by coronary CT angiography (CCTA) for optimal refinement of prognostic risk stratification
June 2020- June 2022
Eligibility Criteria
Patients with stable coronary artery disease
You may qualify if:
- 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
You may not qualify if:
- Individuals unable to provide informed consent
- Non-cardiac illness with life expectancy \< 2 years
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cleerly, Inc.lead
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22904, United States
Related Publications (1)
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.
PMID: 40162910DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
James K Min, MD
Cleerly, Inc.
- STUDY CHAIR
Todd Villines, MD
UVA
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 6 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2020
First Posted
February 21, 2020
Study Start
June 1, 2020
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
November 26, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share