Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)
PoSTCARD
1 other identifier
observational
800
1 country
1
Brief Summary
Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2020
CompletedFirst Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedSeptember 13, 2023
September 1, 2023
2.1 years
June 17, 2020
September 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Time to adverse outcome
Develop time-to-event model for major adverse cardiac events (MACE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject.
>= 2 years
Study Arms (2)
Development / training
Selected by stratified partitioning
Sequestered / test
Selected by stratified partitioning
Interventions
time to event and phenotype classification model
Eligibility Criteria
Reverse chronological, all-comers, design, adjusted for demographic factors
You may qualify if:
- Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease, which was positive for coronary atherosclerotic changes.
- Subject must have been ≥ 18 years of age at the time of the CCTA
You may not qualify if:
- Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
- CCTA taken less than 3 months after deployment of new scanner
- Subject with insufficient CCTA image quality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elucid Bioimaging Inc.lead
- Medical University of South Carolinacollaborator
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J. Buckler, MS
Elucid Bioimaging Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 19, 2020
Study Start
February 5, 2020
Primary Completion
February 28, 2022
Study Completion
July 30, 2022
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share