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Clinical Trials/NCT02803411
NCT02803411
Active, not recruiting
Not Applicable

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

Yonsei University0 sites2,000 target enrollmentMarch 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Heart Disease
Sponsor
Yonsei University
Enrollment
2000
Primary Endpoint
Change in plaque volume and composition detected by follow up CCTA
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
January 2026
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyuk-Jae Chang

Professor

Yonsei University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in plaque volume and composition detected by follow up CCTA

Time Frame: 2 years

Secondary Outcomes

  • Myocardial infarction (yes or no)(2 years)
  • Revascularization (yes or no)(2 years)
  • Cardiac mortality (yes or no)(2 years)
  • Unstable angina requiring hospitalization (yes or no)(2 years)

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