Rationale and design of the CONFIRM2 (Quantitative COroNary CT Angiography Evaluation For Evaluation of Clinical Outcomes: An InteRnational, Multicenter Registry) study

Alexander R. van Rosendael, Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Tami Crabtree, Cleerly, Inc, Denver, CO, United States of America.
Jeroen J. Bax, Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Rine Nakanishi, Department of Cardiovascular Medicine, Toho University Graduate School of Medicine, Tokyo, Japan.
Saima Mushtaq, Department of Perioperative Cardiology and Cardiovascular Imaging, Centro Cardiologico Monzino IRCCS, Milan, Italy.
Gianluca Pontone, Department of Perioperative Cardiology and Cardiovascular Imaging, Centro Cardiologico Monzino IRCCS, Milan, Italy; Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.
Daniele Andreini, Division of University Cardiology, IRCCS Galeazzi Sant'Ambrogio, Department of Biomedical and Clinical Sciences, University of Milan, Italy.
Ronny R. Buechel, Department of Nuclear Medicine, Cardiac Imaging, University Hospital and University of Zurich, Zurich, Switzerland.
Christoph Gräni, Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Gudrun Feuchtner, Department of Radiology, Medical University of Innsbruck, Innsbruck, Austria.
Toral R. Patel, Cardiology at Stroobants Heart and Vascular Institute and UVA Cardiology, Lynchburg, VA, United States of America.
Andrew D. Choi, Cardiology and Radiology, George Washington University, Washington, DC, United States of America.
Mouaz Al-Mallah, Department of Cardiology, Houston Methodist, Houston, TX, United States of America.
Faisal Nabi, Department of Cardiology, Houston Methodist, Houston, TX, United States of America.
Ronald P. Karlsberg, Cardiovascular Research Foundation of Southern California, Cedars Sinai Heart Institute, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, United States of America.
Carlos E. Rochitte, Heart Institute, InCor, University of São Paulo Medical School, São Paulo, Brazil.
Mirvat Alasnag, Cardiac Center, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia.
Ashraf Hamdan, Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
Filippo Cademartiri, Department of Imaging, Fondazione Monasterio/CNR, Pisa, Italy & SYNLAB IRCCS SDN, Naples, Italy.
Hugo Marques, UNICA, Unit of Cardiovascular Imaging, Hospital da Luz, Lisboa and Católica Medical School, Portugal.
Dinesh Kalra, Division of Cardiology, Department of Medicine, University of Louisville School of Medicine, Louisville, KY, United States of America.
David M. German, Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, United States of America.
Himanshu Gupta, Cardiac Imaging, Heart and Vascular Institute, Valley Health System, Ridgewood, NJ, United States of America.
Martin Hadamitzky, Department of Radiology and Nuclear Medicine, German Heart Center Munich, Munich, Germany.
Roderick C. Deaño, Department of Medicine, Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States of America.
Omar Khalique, Division of Cardiovascular Imaging, St. Francis Hospital & Heart Center, Roslyn, NY, United States of America.
Paul Knaapen, Department of Cardiology, Amsterdam University Medical Center, Location VUMC, Amsterdam, The Netherlands.
Udo Hoffmann, Cleerly, Inc, Denver, CO, United States of America.
James Earls, Cleerly, Inc, Denver, CO, United States of America.
James K. Min, Cleerly, Inc, Denver, CO, United States of America.
Ibrahim Danad, Department of Cardiology, Amsterdam University Medical Center, Location VUMC, Amsterdam, The Netherlands; Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands. Electronic address: i.danad@amsterdamumc.nl.

Document Type

Journal Article

Publication Date

11-10-2023

Journal

Journal of cardiovascular computed tomography

DOI

10.1016/j.jcct.2023.10.004

Keywords

Artificial intelligence; Atherosclerosis; Computed tomography angiography; Coronary artery disease; Machine-learning; Prognosis

Abstract

BACKGROUND: In the last 15 years, large registries and several randomized clinical trials have demonstrated the diagnostic and prognostic value of coronary computed tomography angiography (CCTA). Advances in CT scanner technology and developments of analytic tools now enable accurate quantification of coronary artery disease (CAD), including total coronary plaque volume and low attenuation plaque volume. The primary aim of CONFIRM2, (Quantitative COroNary CT Angiography Evaluation For Evaluation of Clinical Outcomes: An InteRnational, Multicenter Registry) is to perform comprehensive quantification of CCTA findings, including coronary, non-coronary cardiac, non-cardiac vascular, non-cardiac findings, and relate them to clinical variables and cardiovascular clinical outcomes. DESIGN: CONFIRM2 is a multicenter, international observational cohort study designed to evaluate multidimensional associations between quantitative phenotype of cardiovascular disease and future adverse clinical outcomes in subjects undergoing clinically indicated CCTA. The targeted population is heterogenous and includes patients undergoing CCTA for atherosclerotic evaluation, valvular heart disease, congenital heart disease or pre-procedural evaluation. Automated software will be utilized for quantification of coronary plaque, stenosis, vascular morphology and cardiac structures for rapid and reproducible tissue characterization. Up to 30,000 patients will be included from up to 50 international multi-continental clinical CCTA sites and followed for 3-4 years. SUMMARY: CONFIRM2 is one of the largest CCTA studies to establish the clinical value of a multiparametric approach to quantify the phenotype of cardiovascular disease by CCTA using automated imaging solutions.

Department

Medicine

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