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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Plaque, Atherosclerotic

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