Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry

James K. Min; Allison Dunning; Fay Y. Lin; Stephan Achenbach; Mouaz H. Al-Mallah; Daniel S. Berman; Matthew J. Budoff; Filippo Cademartiri; Tracy Q. Callister; Hyuk Jae Chang; Victor Cheng; Kavitha M. Chinnaiyan; Benjamin Chow; Augustin Delago; Martin Hadamitzky; Jorg Hausleiter; Ronald P. Karlsberg; Philipp Kaufmann; Erica Maffei; Khurram Nasir; Michael J. Pencina; Gilbert L. Raff; Leslee J. Shaw; Todd C. Villines

doi:10.1016/j.jcct.2011.01.007

Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry

James K. Min, Allison Dunning, Fay Y. Lin, Stephan Achenbach, Mouaz H. Al-Mallah, Daniel S. Berman, Matthew J. Budoff, Filippo Cademartiri, Tracy Q. Callister, Hyuk Jae Chang, Victor Cheng, Kavitha M. Chinnaiyan, Benjamin Chow, Augustin Delago, Martin Hadamitzky, Jorg Hausleiter, Ronald P. Karlsberg, Philipp Kaufmann, Erica Maffei, Khurram NasirMichael J. Pencina, Gilbert L. Raff, Leslee J. Shaw, Todd C. Villines

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

136 Citations (Scopus)

Abstract

Background: 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 (COronary CT Angiography Evaluatio. N For Clinical Outcomes: An Inte. Rnational Multicenter) 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. Methods: 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. Conclusions: From a number of countries worldwide, the information collected from the CONFIRM registry will add incremental and important insights into CCTA findings that confer prognostic value beyond demographic and clinical characteristics. The results of the CONFIRM registry will provide valuable information about the optimal methods for using CCTA findings.

Original language	English
Pages (from-to)	84-92
Number of pages	9
Journal	Journal of Cardiovascular Computed Tomography
Volume	5
Issue number	2
DOIs	https://doi.org/10.1016/j.jcct.2011.01.007
Publication status	Published - 2011 Mar

Bibliographical note

Funding Information:
Conflict of interest: S.A. has received grant support from Siemens and Bayer Schering Pharma and is a consultant for Servier. M.A.-M. has received support from AHA, BCBS Foundation of Michigan, and Astellas . M.J.B. has received modest compensation from the speakers bureau of GE Healthcare. F.C. has received grant support from GE Healthcare . K.C. has received grant support from Bayer Pharma, Blue Cross Blue Shield Blue Care MI . B.C. has received research and fellowship support from GE Healthcare and research support from Pfizer and AstraZeneca and educational support from TeraRecon. J.H. has received research support from Siemens Medical Systems . P.K. has received institutional research support from GE Healthcare and grant support from Swiss National Science Foundation . E.M. has received grant support from GE Healthcare. J.K.M. has received modest compensation from the speakers bureau and medical advisory board and significant research support from GE Healthcare. G.L.R. has received grant support from Siemens, Blue Cross Blue Shield Blue Care MI, and Bayer Pharma . The other authors report no conflicts of interest.

All Science Journal Classification (ASJC) codes

Radiology Nuclear Medicine and imaging
Cardiology and Cardiovascular Medicine

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10.1016/j.jcct.2011.01.007

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Min, J. K., Dunning, A., Lin, F. Y., Achenbach, S., Al-Mallah, M. H., Berman, D. S., Budoff, M. J., Cademartiri, F., Callister, T. Q., Chang, H. J., Cheng, V., Chinnaiyan, K. M., Chow, B., Delago, A., Hadamitzky, M., Hausleiter, J., Karlsberg, R. P., Kaufmann, P., Maffei, E., ... Villines, T. C. (2011). Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry. Journal of Cardiovascular Computed Tomography, 5(2), 84-92. https://doi.org/10.1016/j.jcct.2011.01.007

@article{a462211100dd491790a8779721392876,

title = "Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry",

abstract = "Background: 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 (COronary CT Angiography Evaluatio. N For Clinical Outcomes: An Inte. Rnational Multicenter) 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. Methods: 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. Conclusions: From a number of countries worldwide, the information collected from the CONFIRM registry will add incremental and important insights into CCTA findings that confer prognostic value beyond demographic and clinical characteristics. The results of the CONFIRM registry will provide valuable information about the optimal methods for using CCTA findings.",

author = "Min, {James K.} and Allison Dunning and Lin, {Fay Y.} and Stephan Achenbach and Al-Mallah, {Mouaz H.} and Berman, {Daniel S.} and Budoff, {Matthew J.} and Filippo Cademartiri and Callister, {Tracy Q.} and Chang, {Hyuk Jae} and Victor Cheng and Chinnaiyan, {Kavitha M.} and Benjamin Chow and Augustin Delago and Martin Hadamitzky and Jorg Hausleiter and Karlsberg, {Ronald P.} and Philipp Kaufmann and Erica Maffei and Khurram Nasir and Pencina, {Michael J.} and Raff, {Gilbert L.} and Shaw, {Leslee J.} and Villines, {Todd C.}",

note = "Funding Information: Conflict of interest: S.A. has received grant support from Siemens and Bayer Schering Pharma and is a consultant for Servier. M.A.-M. has received support from AHA, BCBS Foundation of Michigan, and Astellas . M.J.B. has received modest compensation from the speakers bureau of GE Healthcare. F.C. has received grant support from GE Healthcare . K.C. has received grant support from Bayer Pharma, Blue Cross Blue Shield Blue Care MI . B.C. has received research and fellowship support from GE Healthcare and research support from Pfizer and AstraZeneca and educational support from TeraRecon. J.H. has received research support from Siemens Medical Systems . P.K. has received institutional research support from GE Healthcare and grant support from Swiss National Science Foundation . E.M. has received grant support from GE Healthcare. J.K.M. has received modest compensation from the speakers bureau and medical advisory board and significant research support from GE Healthcare. G.L.R. has received grant support from Siemens, Blue Cross Blue Shield Blue Care MI, and Bayer Pharma . The other authors report no conflicts of interest. ",

year = "2011",

month = mar,

doi = "10.1016/j.jcct.2011.01.007",

language = "English",

volume = "5",

pages = "84--92",

journal = "Journal of Cardiovascular Computed Tomography",

issn = "1934-5925",

publisher = "Elsevier Inc.",

number = "2",

}

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 2011, 'Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry', Journal of Cardiovascular Computed Tomography, vol. 5, no. 2, pp. 84-92. https://doi.org/10.1016/j.jcct.2011.01.007

TY - JOUR

T1 - Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry

AU - Min, James K.

AU - Dunning, Allison

AU - Lin, Fay Y.

AU - Achenbach, Stephan

AU - Al-Mallah, Mouaz H.

AU - Berman, Daniel S.

AU - Budoff, Matthew J.

AU - Cademartiri, Filippo

AU - Callister, Tracy Q.

AU - Chang, Hyuk Jae

AU - Cheng, Victor

AU - Chinnaiyan, Kavitha M.

AU - Chow, Benjamin

AU - Delago, Augustin

AU - Hadamitzky, Martin

AU - Hausleiter, Jorg

AU - Karlsberg, Ronald P.

AU - Kaufmann, Philipp

AU - Maffei, Erica

AU - Nasir, Khurram

AU - Pencina, Michael J.

AU - Raff, Gilbert L.

AU - Shaw, Leslee J.

AU - Villines, Todd C.

N1 - Funding Information: Conflict of interest: S.A. has received grant support from Siemens and Bayer Schering Pharma and is a consultant for Servier. M.A.-M. has received support from AHA, BCBS Foundation of Michigan, and Astellas . M.J.B. has received modest compensation from the speakers bureau of GE Healthcare. F.C. has received grant support from GE Healthcare . K.C. has received grant support from Bayer Pharma, Blue Cross Blue Shield Blue Care MI . B.C. has received research and fellowship support from GE Healthcare and research support from Pfizer and AstraZeneca and educational support from TeraRecon. J.H. has received research support from Siemens Medical Systems . P.K. has received institutional research support from GE Healthcare and grant support from Swiss National Science Foundation . E.M. has received grant support from GE Healthcare. J.K.M. has received modest compensation from the speakers bureau and medical advisory board and significant research support from GE Healthcare. G.L.R. has received grant support from Siemens, Blue Cross Blue Shield Blue Care MI, and Bayer Pharma . The other authors report no conflicts of interest.

PY - 2011/3

Y1 - 2011/3

N2 - Background: 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 (COronary CT Angiography Evaluatio. N For Clinical Outcomes: An Inte. Rnational Multicenter) 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. Methods: 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. Conclusions: From a number of countries worldwide, the information collected from the CONFIRM registry will add incremental and important insights into CCTA findings that confer prognostic value beyond demographic and clinical characteristics. The results of the CONFIRM registry will provide valuable information about the optimal methods for using CCTA findings.

AB - Background: 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 (COronary CT Angiography Evaluatio. N For Clinical Outcomes: An Inte. Rnational Multicenter) 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. Methods: 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. Conclusions: From a number of countries worldwide, the information collected from the CONFIRM registry will add incremental and important insights into CCTA findings that confer prognostic value beyond demographic and clinical characteristics. The results of the CONFIRM registry will provide valuable information about the optimal methods for using CCTA findings.

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Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry

Abstract

Bibliographical note

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