We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04279496
Recruitment Status : Enrolling by invitation
First Posted : February 21, 2020
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Cleerly, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The overall objective of CONFIRM2 is to perform the largest cardiovascular phenotype outcomes study ever.

Condition or disease
Coronary Artery Disease

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 35000 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 6 Years
Official Title: Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2026
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with stable coronary artery disease
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279496


Locations
Layout table for location information
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22904
Sponsors and Collaborators
Cleerly, Inc.
Investigators
Layout table for investigator information
Study Chair: James K Min, MD Cleerly, Inc.
Study Chair: Todd Villines, MD UVA
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Cleerly, Inc.
ClinicalTrials.gov Identifier: NCT04279496    
Other Study ID Numbers: Confirm2-Registry
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases