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AtherosclerosisCONFIRMNCT01443637

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

An observational study of Atherosclerosis and Coronary Artery Disease, run by Weill Medical College of Cornell University at 20 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
34,000 participants
Where
20 sitesin 7 countries
Study dates
Jun 2003to 1 Mar 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Age > 18 years
  • Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of standard of care
  • Interpretable CCTA
  • Prospective data collection for CAD risk factors.

Who cannot join

  • No explicit patient exclusion criteria are defined.

Trial locations and contacts

20 sites in 7 countries.

20 sites in 7 countries

United States11 sites

  • Capital Cardiology Associates

    Albany, New York, 12208

  • Emory University

    Atlanta, Georgia, 30322

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Tenessee Heart and Vascular Institute

    Hendersonville, Tennessee, 37035

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Cardiovascular Medical Group of Southern California

    Los Angeles, California, 90210

  • Harbor UCLA

    Los Angeles, California, 90502

  • Baptist Cardiac and Vascular Institute

    Miami, Florida, 33176

  • Weill Cornell Medical Center

    New York, New York, 10021

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20889

Other trials in United States

Canada2 sites

  • Ottawa Heart Institute

    Ottawa, Ontario

  • Providence Health Care

    Vancouver, British Columbia

Other trials in Canada

Germany2 sites

  • University of Giessen

    Giessen

  • Deutsches Herzzentrum Munchen

    Munich

Other trials in Germany

South Korea2 sites

  • Seoul National University College of Medicine

    Seoul

  • Severance Cardiovascular Hospital

    Seoul

Other trials in South Korea

Austria1 site

  • Medical University Innsbruck

    Innsbruck

Other trials in Austria

Italy1 site

  • University of Parma

    Parma

Other trials in Italy

Switzerland1 site

  • University Hospital of Zurich

    Zurich

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Keywords
Coronary Artery Disease, CAD, Atherosclerosis, Myocardial Infarction, MI, CONFIRM, Coronary Computed Tomographic Angiography, CCTA
Medical subject headings
Atherosclerosis, Coronary Artery Disease, Cardiovascular Diseases, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01443637
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary and non-coronary cardiac findings by CCTA

    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.

    Measured: yearly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2011 (estimated)
  2. Study startJun 2003
  3. Primary completion1 Mar 2016
  4. Study completion1 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
34,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01443637
Sponsor's protocol ID
1310014468
Acronym
CONFIRM
Status last verified
Jan 2022
First submitted
28 Sep 2011
Last updated
13 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21477786

  • Cho I, Al'Aref SJ, Berger A, O Hartaigh B, Gransar H, Valenti V, Lin FY, Achenbach S, Berman DS, Budoff MJ, Callister TQ, Al-Mallah MH, Cademartiri F, Chinnaiyan K, Chow BJW, DeLago A, Villines TC, Hadamitzky M, Hausleiter J, Leipsic J, Shaw LJ, Kaufmann PA, Feuchtner G, Kim YJ, Maffei E, Raff G, Pontone G, Andreini D, Marques H, Rubinshtein R, Chang HJ, Min JK. Prognostic value of coronary computed tomographic angiography findings in asymptomatic individuals: a 6-year follow-up from the prospective multicentre international CONFIRM study. Eur Heart J. 2018 Mar 14;39(11):934-941. doi: 10.1093/eurheartj/ehx774.

    PubMed 29365193

  • Lee JH, Han D, Hartaigh BO, Gransar H, Lu Y, Rizvi A, Park MW, Roudsari HM, Stuijfzand WJ, Berman DS, Callister TQ, DeLago A, Hadamitzky M, Hausleiter J, Al-Mallah MH, Budoff MJ, Kaufmann PA, Raff G, Chinnaiyan K, Cademartiri F, Maffei E, Villines TC, Kim YJ, Leipsic J, Feuchtner G, Pontone G, Andreini D, Marques H, Rubinshtein R, Achenbach S, Shaw LJ, Chang HJ, Bax J, Chow B, Cury RC, Gomez M, Jones EC, Lin FY, Min JK, Pena JM. Influence of symptom typicality for predicting MACE in patients without obstructive coronary artery disease: From the CONFIRM Registry (Coronary Computed Tomography Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry). Clin Cardiol. 2018 May;41(5):586-593. doi: 10.1002/clc.22940. Epub 2018 May 11.

    PubMed 29521447

  • van Rosendael AR, Maliakal G, Kolli KK, Beecy A, Al'Aref SJ, Dwivedi A, Singh G, Panday M, Kumar A, Ma X, Achenbach S, Al-Mallah MH, Andreini D, Bax JJ, Berman DS, 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, Pontone G, Raff GL, Rubinshtein R, Shaw LJ, Villines TC, Gransar H, Lu Y, Jones EC, Pena JM, Lin FY, Min JK. Maximization of the usage of coronary CTA derived plaque information using a machine learning based algorithm to improve risk stratification; insights from the CONFIRM registry. J Cardiovasc Comput Tomogr. 2018 May-Jun;12(3):204-209. doi: 10.1016/j.jcct.2018.04.011. Epub 2018 Apr 30.

    PubMed 29753765

  • Cho YK, Nam CW, Koo BK, Schulman-Marcus J, Hartaigh BO, Gransar H, Lu Y, Achenbach S, Al-Mallah M, Andreini D, 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 J, Maffei E, Marques H, Pontone G, Raff GL, Rubinshtein R, Shaw LJ, Villines TC, Berman DS, Jones EC, Pena JM, Lin FY, Min JK. Usefulness of baseline statin therapy in non-obstructive coronary artery disease by coronary computed tomographic angiography: From the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) study. PLoS One. 2018 Dec 12;13(12):e0207194. doi: 10.1371/journal.pone.0207194. eCollection 2018.

    PubMed 30540755

  • Lee JH, Rizvi A, Hartaigh BO, 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 Araujo Goncalves P, Rubinshtein R, Achenbach S, Shaw LJ, Chow BJW, Cury RC, Bax JJ, Chang HJ, Jones EC, Lin FY, Min JK, Pena 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.

    PubMed 30850210

  • Al'Aref SJ, Maliakal G, Singh G, van Rosendael AR, Ma X, Xu Z, Alawamlh OAH, Lee B, Pandey M, Achenbach S, Al-Mallah MH, Andreini D, Bax JJ, Berman DS, 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, Goncalves PA, Pontone G, Raff GL, Rubinshtein R, Villines TC, Gransar H, Lu Y, Jones EC, Pena JM, Lin FY, Min JK, Shaw LJ. Machine learning of clinical variables and coronary artery calcium scoring for the prediction of obstructive coronary artery disease on coronary computed tomography angiography: analysis from the CONFIRM registry. Eur Heart J. 2020 Jan 14;41(3):359-367. doi: 10.1093/eurheartj/ehz565.

    PubMed 31513271

  • 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 Araujo Goncalves P, Pontone G, Raff GL, Rubinshtein R, Villines TC, Lu Y, Pena 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.

    PubMed 31547994

  • Gnanenthiran SR, Naoum C, Leipsic JA, Achenbach S, Al-Mallah MH, Andreini D, Bax JJ, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJW, Cury RC, DeLago A, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufman PA, Kim YJ, Maffei E, Marques H, de Araujo Goncalves P, Pontone G, Raff GL, Rubinshtein R, Shaw LJ, Villines TC, Gransar H, Lu Y, Jones EC, Pena JM, Lin FY, Kritharides L, Min JK. Long-term prognostic utility of computed tomography coronary angiography in older populations. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1279-1286. doi: 10.1093/ehjci/jez067.

    PubMed 30993334

  • Schulman-Marcus J, Lin FY, Gransar H, Berman D, Callister T, DeLago A, Hadamitzky M, Hausleiter J, Al-Mallah M, Budoff M, Kaufmann P, Achenbach S, Raff G, Chinnaiyan K, Cademartiri F, Maffei E, Villines T, Kim YJ, Leipsic J, Feuchtner G, Rubinshtein R, Pontone G, Andreini D, Marques H, Chang HJ, Chow BJW, Cury RC, Dunning A, Shaw L, Min JK. Coronary revascularization vs. medical therapy following coronary-computed tomographic angiography in patients with low-, intermediate- and high-risk coronary artery disease: results from the CONFIRM long-term registry. Eur Heart J Cardiovasc Imaging. 2017 May 1;18(8):841-848. doi: 10.1093/ehjci/jew287.

    PubMed 28329294

  • Deseive S, Shaw LJ, Min JK, Achenbach S, Andreini D, Al-Mallah MH, Berman DS, Budoff MJ, Callister TQ, Cademartiri F, Chang HJ, Chinnaiyan K, Chow BJ, Cury RC, DeLago A, Dunning AM, Feuchtner G, Kaufmann PA, Kim YJ, Leipsic J, Marques H, Maffei E, Pontone G, Raff G, Rubinshtein R, Villines TC, Hausleiter J, Hadamitzky M. Improved 5-year prediction of all-cause mortality by coronary CT angiography applying the CONFIRM score. Eur Heart J Cardiovasc Imaging. 2017 Mar 1;18(3):286-293. doi: 10.1093/ehjci/jew195.

    PubMed 28363203

  • Gebhard C, Maredziak M, Messerli M, Buechel RR, Lin F, Gransar H, Achenbach S, Al-Mallah MH, Andreini D, Bax JJ, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJW, Cury RC, DeLago A, Feuchtner G, Hadamitzky M, Hausleiter J, Kim YJ, Leipsic J, Maffei E, Marques H, Goncalves PA, Pontone G, Raff GL, Rubinshtein R, Shaw LJ, Villines TC, Lu Y, Jones EC, Pena JM, Min JK, Kaufmann PA. Increased long-term mortality in women with high left ventricular ejection fraction: data from the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) long-term registry. Eur Heart J Cardiovasc Imaging. 2020 Apr 1;21(4):363-374. doi: 10.1093/ehjci/jez321.

    PubMed 31985803

  • Opolski MP, Gransar H, Lu Y, Achenbach S, Al-Mallah MH, Andreini D, Bax JJ, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJ, Cury RC, DeLago A, Feuchtner GM, Hadamitzky M, Hausleiter J, Kaufmann PA, Kim YJ, Leipsic JA, Maffei EC, Marques H, Pontone G, Raff G, Rubinshtein R, Shaw LJ, Villines TC, Gomez M, Jones EC, Pena JM, Min JK, Lin FY. Prognostic value of chronic total occlusions detected on coronary computed tomographic angiography. Heart. 2019 Feb;105(3):196-203. doi: 10.1136/heartjnl-2017-312907. Epub 2018 Jul 30.

    PubMed 30061160

  • Naoum C, Berman DS, Ahmadi A, Blanke P, Gransar H, Narula J, Shaw LJ, Kritharides L, Achenbach S, Al-Mallah MH, Andreini D, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow B, Cury RC, DeLago A, Dunning A, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Kim YJ, Maffei E, Marquez H, Pontone G, Raff G, Rubinshtein R, Villines TC, Min J, Leipsic J. Predictive Value of Age- and Sex-Specific Nomograms of Global Plaque Burden on Coronary Computed Tomography Angiography for Major Cardiac Events. Circ Cardiovasc Imaging. 2017 Mar;10(3):e004896. doi: 10.1161/CIRCIMAGING.116.004896.

    PubMed 28292858

  • Opolski MP, O Hartaigh B, Berman DS, Budoff MJ, Achenbach S, Al-Mallah M, Andreini D, Cademartiri F, Chang HJ, Chinnaiyan K, Chow BJ, Hadamitzky M, Hausleiter J, Feuchtner G, Kim YJ, Kaufmann PA, Leipsic J, Maffei E, Pontone G, Raff G, Shaw LJ, Villines TC, Min JK. Current trends in patients with chronic total occlusions undergoing coronary CT angiography. Heart. 2015 Aug;101(15):1212-8. doi: 10.1136/heartjnl-2014-306616. Epub 2015 Jun 15.

    PubMed 26076936

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Coronary Artery Disease, run by Weill Medical College of Cornell University at 20 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada, Germany, South Korea, Austria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary and non-coronary cardiac findings by CCTA (time frame: yearly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01443637, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.

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