Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD) (PoSTCARD)

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: vascuCAP

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 Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Reverse chronological, all-comers, design, adjusted for demographic factors

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Development / training; Selected by stratified partitioning	Device: vascuCAP; time to event and phenotype classification model
Sequestered / test; Selected by stratified partitioning	Device: vascuCAP; time to event and phenotype classification model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Elucid Bioimaging Inc.
• Collaborators: Medical University of South Carolina
• Investigators: Principal Investigator: Andrew J. Buckler, MS, Elucid Bioimaging Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: PoSTCARD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No