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COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM) (CONFIRM)

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: NCT01443637
Recruitment Status : Enrolling by invitation
First Posted : September 30, 2011
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease
Atherosclerosis Coronary Artery Disease Cardiovascular Disease

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry
Actual Study Start Date : June 2003
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Group/Cohort
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.



Primary Outcome Measures :
  1. Coronary and non-coronary cardiac findings by CCTA [ Time Frame: yearly ]
    Identify, quantify, and integrate coronary and noncoronary cardiac findings by Coronary computed tomographic angiography (CCTA) with demographic and clinical data for refinement of risk stratification of persons with suspected or known CAD.



Information from the National Library of Medicine

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

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.

Exclusion Criteria:

No explicit patient exclusion criteria are defined.


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): NCT01443637


Locations
Show Show 20 study locations
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Leslee J Shaw, PhD Weill Cornell Medicine
Publications:
Lee JH, Rizvi A, Hartaigh BÓ, Han D, Park MW, Roudsari HM, Stuijfzand WJ, Gransar H, Lu Y, Callister TQ, Berman DS, DeLago A, Hadamitzky M, Hausleiter J, Al-Mallah MH, Budoff MJ, Kaufmann PA, Raff GL, Chinnaiyan K, Cademartiri F, Maffei E, Villines TC, Kim YJ, Leipsic J, Feuchtner G, Pontone G, Andreini D, Marques H, de Araújo Gonçalves P, Rubinshtein R, Achenbach S, Shaw LJ, Chow BJW, Cury RC, Bax JJ, Chang HJ, Jones EC, Lin FY, Min JK, Peña JM. The Predictive Value of Coronary Artery Calcium Scoring for Major Adverse Cardiac Events According to Renal Function (from the Coronary Computed Tomography Angiography Evaluation for Clinical Outcomes: An International Multicenter [CONFIRM] Registry). Am J Cardiol. 2019 May 1;123(9):1435-1442. doi: 10.1016/j.amjcard.2019.01.055. Epub 2019 Feb 10.
Han D, Beecy A, Anchouche K, Gransar H, Dunham PC, Lee JH, Achenbach S, Al-Mallah MH, Andreini D, Berman DS, Bax JJ, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJW, Cury RC, DeLago A, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Kim YJ, Leipsic JA, Maffei E, Marques H, de Araújo Gonçalves P, Pontone G, Raff GL, Rubinshtein R, Villines TC, Lu Y, Peña JM, Shaw LJ, Min JK, Lin FY. Risk Reclassification With Coronary Computed Tomography Angiography-Visualized Nonobstructive Coronary Artery Disease According to 2018 American College of Cardiology/American Heart Association Cholesterol Guidelines (from the Coronary Computed Tomography Angiography Evaluation for Clinical Outcomes : An International Multicenter Registry [CONFIRM]). Am J Cardiol. 2019 Nov 1;124(9):1397-1405. doi: 10.1016/j.amjcard.2019.07.045. Epub 2019 Aug 23.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01443637    
Other Study ID Numbers: 1310014468
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Coronary Artery Disease
CAD
Atherosclerosis
Myocardial Infarction
MI
CONFIRM
Coronary Computed Tomographic Angiography
CCTA
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases