Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: vascuCAP

• Registration Number: NCT04439643
• Lead Sponsor: Elucid Bioimaging Inc.

Brief Summary

Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.

Detailed Description

Develop time-to-event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as last known well dates.

Study Timeline

• Study Start: 2020-02-05
• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Primary Completion: 2022-02-28
• Study Completion: 2022-07-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sequestered / test	vascuCAP	Selected by stratified partitioning
Development / training	vascuCAP	Selected by stratified partitioning

Primary Outcome Measures

Name	Time	Method
Time to adverse outcome	>= 2 years	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States