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

Autor: van Rosendael AR; Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands., Crabtree T; Cleerly, Inc, Denver, CO, United States of America., Bax JJ; Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands., Nakanishi R; Department of Cardiovascular Medicine, Toho University Graduate School of Medicine, Tokyo, Japan., Mushtaq S; Department of Perioperative Cardiology and Cardiovascular Imaging, Centro Cardiologico Monzino IRCCS, Milan, Italy., Pontone G; 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., Andreini D; Division of University Cardiology, IRCCS Galeazzi Sant'Ambrogio, Department of Biomedical and Clinical Sciences, University of Milan, Italy., Buechel RR; Department of Nuclear Medicine, Cardiac Imaging, University Hospital and University of Zurich, Zurich, Switzerland., Gräni C; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Feuchtner G; Department of Radiology, Medical University of Innsbruck, Innsbruck, Austria., Patel TR; Cardiology at Stroobants Heart and Vascular Institute and UVA Cardiology, Lynchburg, VA, United States of America., Choi AD; Cardiology and Radiology, George Washington University, Washington, DC, United States of America., Al-Mallah M; Department of Cardiology, Houston Methodist, Houston, TX, United States of America., Nabi F; Department of Cardiology, Houston Methodist, Houston, TX, United States of America., Karlsberg RP; 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., Rochitte CE; Heart Institute, InCor, University of São Paulo Medical School, São Paulo, Brazil., Alasnag M; Cardiac Center, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia., Hamdan A; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel., Cademartiri F; Department of Imaging, Fondazione Monasterio/CNR, Pisa, Italy & SYNLAB IRCCS SDN, Naples, Italy., Marques H; UNICA, Unit of Cardiovascular Imaging, Hospital da Luz, Lisboa and Católica Medical School, Portugal., Kalra D; Division of Cardiology, Department of Medicine, University of Louisville School of Medicine, Louisville, KY, United States of America., German DM; Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, United States of America., Gupta H; Cardiac Imaging, Heart and Vascular Institute, Valley Health System, Ridgewood, NJ, United States of America., Hadamitzky M; Department of Radiology and Nuclear Medicine, German Heart Center Munich, Munich, Germany., Deaño RC; Department of Medicine, Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States of America., Khalique O; Division of Cardiovascular Imaging, St. Francis Hospital & Heart Center, Roslyn, NY, United States of America., Knaapen P; Department of Cardiology, Amsterdam University Medical Center, Location VUMC, Amsterdam, The Netherlands., Hoffmann U; Cleerly, Inc, Denver, CO, United States of America., Earls J; Cleerly, Inc, Denver, CO, United States of America., Min JK; Cleerly, Inc, Denver, CO, United States of America., Danad I; 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.
Jazyk: angličtina
Zdroj: Journal of cardiovascular computed tomography [J Cardiovasc Comput Tomogr] 2024 Jan-Feb; Vol. 18 (1), pp. 11-17. Date of Electronic Publication: 2023 Nov 10.
DOI: 10.1016/j.jcct.2023.10.004
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Alexander R. van Rosendael is a member, Cleerly Scientific Advisory Board. Tami Crabtree is an employee and equity holder, Cleerly, Inc. Gianluca Pontone has received honorarium as speaker/consultant and/or institutional research grant from GE Healthcare, Bracco, Medtronic, Novartis. Ronny R. Buechel reports receiving speaking honoraria from GE Healthcare, Pfizer, Gilead, and IBA. Christoph Gräni received funding from the Swiss National Science foundation, InnoSuisse, CAIM foundation, GAMBIT foundation, Novartis foundation for biomedical research, outside of the submitted work. Andrew D. Choi is a consultant for Siemens, holds equity in Cleerly, and receives grant support from the George Washing Heart and Vascular Institute.Carlos E. Rochitte reports receiving speaking honoraria for Pfizer, Edwards, GE, and Manole. David M. German reports no conflicts Himanshu Gupta reports no conflicts. Omar Khalique is a consultant for Edwards, Croivalve, Restore Medical, holds equity in Triflo, and has received honoraria for educational programs from Heartflow. Udo Hoffmann is an employee and equity holder, Cleerly, Inc., and has received honoraria from Stanford University, Clinical Cardiovascular Sciences, Rapid AI, MedTrace. James Earls is an employee and equity holder, Cleerly, Inc. James K. Min is an employee and equity holder, Cleerly, Inc. and a member of the Arineta Medical Advisory Board. Ibrahim Danad is a member, Cleerly Scientific Advisory Board. Hugo Marques is a consultant for Cleerly, Inc.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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