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Enrolling by invitation NCT04279496

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

Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter

Overview

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.

Primary outcome measures

  • Coronary CT Angiography EvaluatioN For Clinical Outcomes [Time frame: June 2020- June 2022]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University of Virginia — Charlottesville

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, Feren PMID 40162910

Identifiers

NCT: NCT04279496 · Confirm2-Registry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗