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

Sang Eun Lee, Hyuk-Jae Chang, Asim Rizvi, Martin Hadamitzky, Yong Jin Kim, Edoardo Conte, Daniele Andreini, Gianluca Pontone, Valentina Volpato, Matthew J. Budoff, Ilan Gottlieb, Byoung Kwon Lee, Eun Ju Chun, Filippo Cademartiri, Erica Maffei, Hugo Marques, Jonathon A. Leipsic, Sanghoon Shin, Jung Hyun Choi, Namsik ChungJames K. Min

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

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. Design The PARADIGM registry (ClinicalTrials.gov NCT02803411) 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. Summary 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.

Original languageEnglish
Pages (from-to)72-79
Number of pages8
JournalAmerican heart journal
Volume182
DOIs
Publication statusPublished - 2016 Dec 1

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Atherosclerotic Plaques
Registries
Angiography
Coronary Artery Disease
Demography
Unstable Angina
Hospitalization
Myocardial Infarction

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Lee, Sang Eun ; Chang, Hyuk-Jae ; Rizvi, Asim ; Hadamitzky, Martin ; Kim, Yong Jin ; Conte, Edoardo ; Andreini, Daniele ; Pontone, Gianluca ; Volpato, Valentina ; Budoff, Matthew J. ; Gottlieb, Ilan ; Lee, Byoung Kwon ; Chun, Eun Ju ; Cademartiri, Filippo ; Maffei, Erica ; Marques, Hugo ; Leipsic, Jonathon A. ; Shin, Sanghoon ; Choi, Jung Hyun ; Chung, Namsik ; Min, James K. / 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. In: American heart journal. 2016 ; Vol. 182. pp. 72-79.
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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 = "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. Design The PARADIGM registry (ClinicalTrials.gov NCT02803411) 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. Summary 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.",
author = "Lee, {Sang Eun} and Hyuk-Jae Chang and Asim Rizvi and Martin Hadamitzky and Kim, {Yong Jin} and Edoardo Conte and Daniele Andreini and Gianluca Pontone and Valentina Volpato and Budoff, {Matthew J.} and Ilan Gottlieb and Lee, {Byoung Kwon} and Chun, {Eun Ju} and Filippo Cademartiri and Erica Maffei and Hugo Marques and Leipsic, {Jonathon A.} and Sanghoon Shin and Choi, {Jung Hyun} and Namsik Chung and Min, {James K.}",
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Lee, SE, Chang, H-J, Rizvi, A, Hadamitzky, M, Kim, YJ, Conte, E, Andreini, D, Pontone, G, Volpato, V, Budoff, MJ, Gottlieb, I, Lee, BK, Chun, EJ, Cademartiri, F, Maffei, E, Marques, H, Leipsic, JA, Shin, S, Choi, JH, Chung, N & Min, JK 2016, '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', American heart journal, vol. 182, pp. 72-79. https://doi.org/10.1016/j.ahj.2016.09.003

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. / Lee, Sang Eun; Chang, Hyuk-Jae; Rizvi, Asim; Hadamitzky, Martin; Kim, Yong Jin; Conte, Edoardo; Andreini, Daniele; Pontone, Gianluca; Volpato, Valentina; Budoff, Matthew J.; Gottlieb, Ilan; Lee, Byoung Kwon; Chun, Eun Ju; Cademartiri, Filippo; Maffei, Erica; Marques, Hugo; Leipsic, Jonathon A.; Shin, Sanghoon; Choi, Jung Hyun; Chung, Namsik; Min, James K.

In: American heart journal, Vol. 182, 01.12.2016, p. 72-79.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Rationale and design of the Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography IMaging (PARADIGM) registry

T2 - A comprehensive exploration of plaque progression and its impact on clinical outcomes from a multicenter serial coronary computed tomographic angiography study

AU - Lee, Sang Eun

AU - Chang, Hyuk-Jae

AU - Rizvi, Asim

AU - Hadamitzky, Martin

AU - Kim, Yong Jin

AU - Conte, Edoardo

AU - Andreini, Daniele

AU - Pontone, Gianluca

AU - Volpato, Valentina

AU - Budoff, Matthew J.

AU - Gottlieb, Ilan

AU - Lee, Byoung Kwon

AU - Chun, Eun Ju

AU - Cademartiri, Filippo

AU - Maffei, Erica

AU - Marques, Hugo

AU - Leipsic, Jonathon A.

AU - Shin, Sanghoon

AU - Choi, Jung Hyun

AU - Chung, Namsik

AU - Min, James K.

PY - 2016/12/1

Y1 - 2016/12/1

N2 - 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. Design The PARADIGM registry (ClinicalTrials.gov NCT02803411) 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. Summary 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.

AB - 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. Design The PARADIGM registry (ClinicalTrials.gov NCT02803411) 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. Summary 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.

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