Coronary Artery Disease Clinical Trial
— CONFIRMOfficial title:
COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry
NCT number | NCT01443637 |
Other study ID # | 1310014468 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2003 |
Est. completion date | March 1, 2016 |
Verified date | January 2022 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 34000 |
Est. completion date | March 1, 2016 |
Est. primary completion date | March 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Innsbruck | Innsbruck | |
Canada | Ottawa Heart Institute | Ottawa | Ontario |
Canada | Providence Health Care | Vancouver | British Columbia |
Germany | University of Giessen | Giessen | |
Germany | Deutsches Herzzentrum Munchen | Munich | |
Italy | University of Parma | Parma | |
Korea, Republic of | Seoul National University College of Medicine | Seoul | |
Korea, Republic of | Severance Cardiovascular Hospital | Seoul | |
Switzerland | University Hospital of Zurich | Zurich | |
United States | Capital Cardiology Associates | Albany | New York |
United States | Emory University | Atlanta | Georgia |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Tenessee Heart and Vascular Institute | Hendersonville | Tennessee |
United States | Cardiovascular Medical Group of Southern California | Los Angeles | California |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Harbor UCLA | Los Angeles | California |
United States | Baptist Cardiac and Vascular Institute | Miami | Florida |
United States | Weill Cornell Medical Center | New York | New York |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States, Austria, Canada, Germany, Italy, Korea, Republic of, Switzerland,
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, Gonçalves PA, Pontone G, Raff GL, Rubinshtein R, Villines TC, Gransar H, Lu Y, Jones EC, Peña 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. — View Citation
Cho I, Al'Aref SJ, Berger A, Ó 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. — View Citation
Cho YK, Nam CW, Koo BK, Schulman-Marcus J, Hartaigh BÓ, 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, Peña 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. — View Citation
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. Erratum in: Eur Heart J Cardiovasc Imaging. 2017 Jun 1;18(6):706. — View Citation
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 Araújo Gonçalves P, Pontone G, Raff GL, Rubinshtein R, Shaw LJ, Villines TC, Gransar H, Lu Y, Jones EC, Peña 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. Erratum in: Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1286. — View Citation
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. — View Citation
Lee JH, Han D, Hartaigh BÓ, 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, Peña 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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, Peña 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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