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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02803411
Acronym
PARADIGM
Enrollment
2000
Registered
2016-06-17
Start date
2003-03-31
Completion date
2026-01-31
Last updated
2018-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Coronary Heart Disease, Coronary Computed Tomography Angiography (CCTA), Coronary Atherosclerotic Plaque, coronary atherosclerosis

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.

Interventions

None listed

Sponsors

Montreal Heart Institute
CollaboratorOTHER
Hospital da Luz, Portugal
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
Centro Cardiologico Monzino
CollaboratorOTHER
University of British Columbia
CollaboratorOTHER
German Heart Institute
CollaboratorOTHER
National Institute of Cardiology, Laranjeiras, Brazil
CollaboratorOTHER_GOV
Weill Medical College of Cornell University
CollaboratorOTHER
Cedars-Sinai Medical Center
CollaboratorOTHER
Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in plaque volume and composition detected by follow up CCTA2 years

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 8, 2026