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

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ClinicalTrials.gov Identifier: NCT02803411
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
Montreal Heart Institute
Hospital da Luz, Portugal
University of California, Los Angeles
Centro Cardiologico Monzino
University of British Columbia
German Heart Institute
National Institute of Cardiology, Laranjeiras, Brazil
Weill Medical College of Cornell University
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Hyuk-Jae Chang, Yonsei University

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.

Condition or disease
Coronary Heart Disease

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)
Study Start Date : March 2003
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026



Primary Outcome Measures :
  1. Change in plaque volume and composition detected by follow up CCTA [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Cardiac mortality (yes or no) [ Time Frame: 2 years ]
  2. Myocardial infarction (yes or no) [ Time Frame: 2 years ]
  3. Unstable angina requiring hospitalization (yes or no) [ Time Frame: 2 years ]
  4. Revascularization (yes or no) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803411


Sponsors and Collaborators
Yonsei University
Montreal Heart Institute
Hospital da Luz, Portugal
University of California, Los Angeles
Centro Cardiologico Monzino
University of British Columbia
German Heart Institute
National Institute of Cardiology, Laranjeiras, Brazil
Weill Medical College of Cornell University
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Hyuk-Jae Chang, MD, PhD Yonsei Univerity
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hyuk-Jae Chang, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02803411    
Other Study ID Numbers: 4-2016-0263
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hyuk-Jae Chang, Yonsei University:
Coronary Heart Disease
Coronary Computed Tomography Angiography (CCTA)
Coronary Atherosclerotic Plaque
coronary atherosclerosis
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Plaque, Atherosclerotic
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathological Conditions, Anatomical