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NCT02803411 Clinical Trial

Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)

Coronary Heart Disease Clinical Trial

— PARADIGM  

Official title:
Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02803411
Other study ID # 4-2016-0263
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2003
Est. completion date January 2026

Study information
Verified date June 2018
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To describe the natural history of the coronary atherosclerotic plaque development and progression over time by CCTA with demographic and laboratory data for refinement of risk stratification of patients referred for CCTA.

Description:

All PARADIGM study patients underwent initial and follow-up CCTA based on order from their primary physician. Demographic data, targeted medical history, cardiovascular risk factors, and laboratory data was prospectively collected in electronic case report forms (eCRFs) at the time of the initial CCTA and at the time of follow-up CCTA.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients underwent two or more clinically indicated CCTA with 64-detector rows or greater for CAD evaluation

- patients underwent at least 2 year interval between the baseline and follow-up CCTA

Exclusion Criteria:

- poor image quality of CCTA

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (10)
Lead Sponsor Collaborator
Yonsei University Cedars-Sinai Medical Center, Centro Cardiologico Monzino, German Heart Institute, Hospital da Luz, Portugal, Montreal Heart Institute, National Institute of Cardiology, Laranjeiras, Brazil, University of British Columbia, University of California, Los Angeles, Weill Medical College of Cornell University

References & Publications (1)

Lee SE, Chang HJ, 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. 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. Am Heart J. 2016 Dec;182:72-79. doi: 10.1016/j.ahj.2016.09.003. Epub 2016 Sep 22. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in plaque volume and composition detected by follow up CCTA 2 years
Secondary Cardiac mortality (yes or no) 2 years
Secondary Myocardial infarction (yes or no) 2 years
Secondary Unstable angina requiring hospitalization (yes or no) 2 years
Secondary Revascularization (yes or no) 2 years
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