Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry (CONFIRM2)

• ClinicalTrials.gov Identifier: NCT04279496
• Recruitment Status: Enrolling by invitation
• First Posted: February 21, 2020
• Last Update Posted: September 10, 2021
• Sponsor: Cleerly, Inc.
• Information provided by (Responsible Party): Cleerly, Inc.

Tracking Information

• First Submitted Date: February 19, 2020
• First Posted Date: February 21, 2020
• Last Update Posted Date: September 10, 2021
• Actual Study Start Date: June 1, 2020
• Estimated Primary Completion Date: June 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 19, 2020)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry
• Official Title: Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Other
• Target Follow-Up Duration: 6 Years
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients with stable coronary artery disease
• Condition: Coronary Artery Disease
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: February 19, 2020): 35000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2026
• Estimated Primary Completion Date: June 1, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04279496
• Other Study ID Numbers: Confirm2-Registry
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Cleerly, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Cleerly, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: James K Min, MD; Cleerly, Inc.
• Study Chair: Todd Villines, MD; UVA

• PRS Account: Cleerly, Inc.
• Verification Date: September 2021