Clinical trial NCT02803411: Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)
Official title: Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
Coronary Computed Tomography Angiography (CCTA)
Coronary Atherosclerotic Plaque
coronary atherosclerosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Montreal Heart Institute
name: Hospital da Luz, Portugal
name: University of California, Los Angeles
name: Centro Cardiologico Monzino
name: University of British Columbia
name: German Heart Institute
name: National Institute of Cardiology, Laranjeiras, Brazil
name: Weill Medical College of Cornell University
name: Cedars-Sinai Medical Center
First posted: 2016-06-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population is patients with suspected or known CAD who had undergone serial CCTA by physician referral. Sites that had collected cohorts of CCTA patients with symptoms, risk factors, CCTA image data, and outcomes were invited to contribute data for a merged database. This sample includes patients with suspected or known CAD, and asymptomatic subjects undergoing CCTA for risk stratification to evaluate the significance of changes in CCTA findings in different clinical contexts.

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.

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

Primary outcomes:
measure: Change in plaque volume and composition detected by follow up CCTA
timeFrame: 2 years
Secondary outcomes:
measure: Cardiac mortality (yes or no)
timeFrame: 2 years
measure: Myocardial infarction (yes or no)
timeFrame: 2 years
measure: Unstable angina requiring hospitalization (yes or no)
timeFrame: 2 years
measure: Revascularization (yes or no)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Yonsei Univerity
name: Hyuk-Jae Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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