Coronary Artery DiseaseCONFIRM2NCT04279496
Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry
An observational study of Coronary Artery Disease, run by Cleerly, Inc. at 1 site in United States.
Trial summary
The overall objective of CONFIRM2 is to perform the largest cardiovascular phenotype outcomes study ever. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 15,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 1 Jun 2027
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable coronary artery disease
Who may be able to join
- 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
Who cannot join
- Individuals unable to provide informed consent
- Non-cardiac illness with life expectancy < 2 years
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
About this study
Official title: 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.
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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: June 2020- June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Cleerly, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James K Min, MD, Study chair, Cleerly, Inc.Udo Hoffmann, MD, Study chair, Cleerly, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279496
- Sponsor's protocol ID
- Confirm2-Registry
- Acronym
- CONFIRM2
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2020
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter
- ClinicalTrials.gov ID
- NCT04279496
- Acronym / sponsor ID
- CONFIRM2 / Confirm2-Registry
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Cleerly, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable coronary artery disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals unable to provide informed consent
- Non-cardiac illness with life expectancy < 2 years
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 40162910Feuchtner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James K Min, MD study chair
Cleerly, Inc.
Udo Hoffmann, MD study chair
Cleerly, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Cleerly, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary CT Angiography EvaluatioN For Clinical Outcomes (time frame: June 2020- June 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.