title: Rationale and design of the Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography IMaging (PARADIGM) registry: A comprehensive exploration of plaque progression and its impact on clinical outcomes from a multicenter serial coronary computed tomographic angiography study.
abstract: BACKGROUND
  The natural history of coronary artery disease (CAD) in patients with low-to-intermediate risk is not well characterized. Although earlier invasive serial studies have documented the progression of atherosclerotic burden, most were focused on high-risk patients only. The PARADIGM registry is a large, prospective, multinational dynamic observational registry of patients undergoing serial coronary computed tomographic angiography (CCTA). The primary aim of PARADIGM is to characterize the natural history of CAD in relation to clinical and laboratory data.
  
  
  METHODS
  The PARADIGM registry (ClinicalTrials.govNCT02803411) comprises ≥2,000 consecutive patients across 9 cluster sites in 7 countries. PARADIGM sites were chosen on the basis of adequate CCTA volume, site CCTA proficiency, local demographic characteristics, and medical facilities to ensure a broad-based sample of patients. Patients referred for clinically indicated CCTA will be followed up and enrolled if they had a second CCTA scan. Patients will also be followed up beyond serial CCTA performance to identify adverse CAD events that include cardiac and noncardiac death, myocardial infarction, unstable angina, target vessel revascularization, and CAD-related hospitalization.
  
  
  CONCLUSIONS
  The results derived from the PARADIGM registry are anticipated to add incremental insight into the changes in CCTA findings in accordance with the progression or regression of CAD that confer prognostic value beyond demographic and clinical characteristics.
authors.affiliation: Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University Health System, Seoul, South Korea.
authors.forename: Sang-Eun
authors.initials: SE
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University Health System, Seoul, South Korea. Electronic address: hjchang@yuhs.ac.
authors.forename: Hyuk-Jae
authors.initials: HJ
authors.lastname: Chang
authors.affiliation: Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medical College, New York, NY, USA.
authors.forename: Asim
authors.initials: A
authors.lastname: Rizvi
authors.affiliation: Division of Cardiology, University of Munich, Munich, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Hadamitzky
authors.affiliation: Seoul National University Hospital, South Korea.
authors.forename: Yong-Jin
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Centro Cardiologico Monzino, IRCCS, Milan, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Conte
authors.affiliation: Centro Cardiologico Monzino, IRCCS, Milan, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Andreini
authors.affiliation: Centro Cardiologico Monzino, IRCCS, Milan, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Pontone
authors.affiliation: Centro Cardiologico Monzino, IRCCS, Milan, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Volpato
authors.affiliation: Department of Medicine, Harbor UCLA Medical Center, Los Angeles, CA, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Budoff
authors.affiliation: Department of Radiology, Casa de Saude São Jose, Rio de Janeiro, Brazil.
authors.forename: Ilan
authors.initials: I
authors.lastname: Gottlieb
authors.affiliation: Gangnam Severance Hospital, South Korea.
authors.forename: Byoung Kwon
authors.initials: BK
authors.lastname: Lee
authors.affiliation: Seoul National University Bundang Hospital, South Korea.
authors.forename: Eun Ju
authors.initials: EJ
authors.lastname: Chun
authors.affiliation: Department of Radiology, Montréal Heart Institute/Université de Montréal, Montréal, Quebec, Canada.
authors.forename: Filippo
authors.initials: F
authors.lastname: Cademartiri
authors.affiliation: Department of Radiology, Montréal Heart Institute/Université de Montréal, Montréal, Quebec, Canada.
authors.forename: Erica
authors.initials: E
authors.lastname: Maffei
authors.affiliation: Hospital da Luz, Lisbon, Portugal.
authors.forename: Hugo
authors.initials: H
authors.lastname: Marques
authors.affiliation: Department of Radiology, St Paul's Hospital, University of British Columbia, Vancouver, Canada.
authors.forename: Jonathon A
authors.initials: JA
authors.lastname: Leipsic
authors.affiliation: National Health Insurance Service Ilsan Hospital, South Korea.
authors.forename: Sanghoon
authors.initials: S
authors.lastname: Shin
authors.affiliation: Busan University Hospital, South Korea.
authors.forename: Jung Hyun
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University Health System, Seoul, South Korea.
authors.forename: Namsik
authors.initials: N
authors.lastname: Chung
authors.affiliation: Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medical College, New York, NY, USA. Electronic address: jkm2001@med.cornell.edu.
authors.forename: James K
authors.initials: JK
authors.lastname: Min
mesh_terms: D000328:Adult; D000368:Aged; D000072226:Computed Tomography Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058226:Plaque, Atherosclerotic / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology; D011237:Predictive Value of Tests; D011379:Prognosis; D012042:Registries; D018570:Risk Assessment / Q000379:methods