The CONFIRM Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
James K. Min, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01443637
First received: September 28, 2011
Last updated: July 27, 2012
Last verified: July 2012

September 28, 2011
July 27, 2012
June 2003
January 2016   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01443637 on ClinicalTrials.gov Archive Site
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The CONFIRM Registry
COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry

The CONFIRM study was developed to examine the prognostic value of cardiac computed tomographic angiography (CCTA) findings for prediction of future adverse cardiac events related to coronary artery disease (CAD) in a large, international patient population. The purpose of this multicenter registry is to correlate coronary and non-coronary cardiac findings by CCTA with demographic and clinical data for refinement of risk stratification of individuals with suspected or known CAD.

Coronary computed tomographic angiography (CCTA) of 64-detector rows or greater represents a novel noninvasive anatomic method for evaluation of patients with suspected coronary artery disease (CAD). Early studies suggest a potential for prognostic risk assessment by CCTA findings but were limited by small patient cohorts or single centers. The CONFIRM Registry is a large, prospective, multinational dynamic observational study of patients undergoing CCTA. The primary aim of CONFIRM is to determine the prognostic value of CCTA findings for the prediction of future adverse CAD events.

The CONFIRM registry currently represents 27,125 consecutive patients at 12 cluster sites in 6 countries in North America, Europe, and Asia. CONFIRM sites were chosen on the basis of adequate CCTA volume, site CCTA proficiency, and local demographic characteristics and medical facilities to ensure a broad-based sample of patients. Patients comprising the present CONFIRM cohort include those with suspected but without known CAD, with known CAD, or asymptomatic persons undergoing CAD evaluation. A data dictionary comprising a wide array of demographic, clinical, and CCTA findings was developed by the CONFIRM investigators and is uniformly used for all patients. Patients are followed up after CCTA performance to identify adverse CAD events, including death, myocardial infarction, unstable angina, target vessel revascularization, and CAD-related hospitalization.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

The study population consist of patients at multiple international centers undergoing clinically-indicated coronary CT angiography as part of their standard of care.

  • Atherosclerosis
  • Coronary Artery Disease
  • Cardiovascular Disease
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Coronary CT Angiography (CCTA)
Patients included in the CONFIRM Registry are those that have previously undergone clinically-indicated CCTA as part of their standard of care.
Min JK, Dunning A, Lin FY, Achenbach S, Al-Mallah MH, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Cheng V, Chinnaiyan KM, Chow B, Delago A, Hadamitzky M, Hausleiter J, Karlsberg RP, Kaufmann P, Maffei E, Nasir K, Pencina MJ, Raff GL, Shaw LJ, Villines TC. Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry. J Cardiovasc Comput Tomogr. 2011 Mar-Apr;5(2):84-92. doi: 10.1016/j.jcct.2011.01.007. Epub 2011 Feb 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50000
Not Provided
January 2016   (final data collection date for primary outcome measure)

All consecutive patients at cluster sites meeting all inclusion criteria undergoing CCTA of 64-detector rows or greater will be included within the CONFIRM registry.

Inclusion Criteria:

  1. Age > 18 years
  2. Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of standard of care
  3. Interpretable CCTA
  4. Prospective data collection for CAD risk factors.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Germany,   Italy,   Korea, Republic of,   Switzerland
 
NCT01443637
CTG1
No
James K. Min, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: James K Min, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP