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

NCT01443637 | Completed

• 1 other identifier: 1310014468
• Study Type: observational
• Target: 34,000
• Locations: 7 countries
• Sites: 20

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.

Conditions

Atherosclerosis; Coronary Artery Disease; Cardiovascular Disease

Keywords

Coronary Artery Disease; CAD; Atherosclerosis; Myocardial Infarction; MI; CONFIRM; Coronary Computed Tomographic Angiography; CCTA

Outcome Measures

Primary Outcomes (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.

  yearly

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (20)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Cardiovascular Medical Group of Southern California

Los Angeles, California, 90210, United States

Location

Harbor UCLA

Los Angeles, California, 90502, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20889, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Capital Cardiology Associates

Albany, New York, 12208, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Tenessee Heart and Vascular Institute

Hendersonville, Tennessee, 37035, United States

Location

Medical University Innsbruck

Innsbruck, Austria

Location

Providence Health Care

Vancouver, British Columbia, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

University of Giessen

Giessen, Germany

Location

Deutsches Herzzentrum Munchen

Munich, Germany

Location

University of Parma

Parma, Italy

Location

Seoul National University College of Medicine

Seoul, South Korea

Location

Severance Cardiovascular Hospital

Seoul, South Korea

Location

University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (16)

• 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.

  PMID: 21477786 BACKGROUND

• 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.

  PMID: 29365193 BACKGROUND

• 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.

  PMID: 29521447 BACKGROUND

• 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.

  PMID: 29753765 BACKGROUND

• 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.

  PMID: 30540755 BACKGROUND

• 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.

  PMID: 30850210 BACKGROUND

• 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.

  PMID: 31513271 BACKGROUND

• 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.

  PMID: 31547994 BACKGROUND

• 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.

  PMID: 30993334 BACKGROUND

• 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.

  PMID: 28329294 BACKGROUND

• 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.

  PMID: 28363203 BACKGROUND

• 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.

  PMID: 31985803 DERIVED

• 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.

  PMID: 30061160 DERIVED

• 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.

  PMID: 28292858 DERIVED

• 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.

  PMID: 26076936 DERIVED

• Chow BJ, Small G, Yam Y, Chen L, McPherson R, Achenbach S, Al-Mallah M, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Cheng VY, Chinnaiyan K, Cury R, Delago A, Dunning A, Feuchtner G, Hadamitzky M, Hausleiter J, Karlsberg RP, Kaufmann PA, Kim YJ, Leipsic J, LaBounty T, Lin F, Maffei E, Raff GL, Shaw LJ, Villines TC, Min JK; CONFIRM Investigators. Prognostic and therapeutic implications of statin and aspirin therapy in individuals with nonobstructive coronary artery disease: results from the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter registry) registry. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):981-9. doi: 10.1161/ATVBAHA.114.304351. Epub 2015 Feb 12.

  PMID: 25676000 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Cardiovascular Diseases; Myocardial Infarction

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Leslee J Shaw, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: June 1, 2003
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 13, 2022

Record last verified: 2022-01

Locations

US (11); DE (2); KR (2); CH (1); IT (1); AU (1); CA (2)