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Enrolling by invitationNCT04279496CONFIRM2Updated Jun 5, 2026

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

An observational study in Coronary Artery Disease, sponsored by Cleerly, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Cleerly, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
15,000
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Cleerly, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with stable coronary artery disease

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Other
Enrollment
15,000 participants (estimated)
Target follow-up
6 Years
Patient registry
Yes
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What researchers measure

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

    Time frame: June 2020- June 2022

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Study locations

1 site
  • University of Virginia
    Charlottesville, Virginia 22904, United States
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References and documents

Publications

  • 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. PubMed 40162910 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04279496
Lead sponsor
Cleerly, Inc.
Responsible party
Sponsor
First posted
Feb 21, 2020
Start date
Jun 1, 2020
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jun 5, 2026

Study contacts

James K Min, MD
study chair · Cleerly, Inc.
Udo Hoffmann, MD
study chair · Cleerly, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Cleerly, Inc.

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