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NCT04279496 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— CONFIRM2  

Official title:
Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04279496
Other study ID # Confirm2-Registry
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 1, 2027

Study information
Verified date July 2023
Source Cleerly, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 35000
Est. completion date June 1, 2027
Est. primary completion date June 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)
Lead Sponsor Collaborator
Cleerly, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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