Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

NCT ID: NCT04439643

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-05

Study Completion Date

2022-07-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Development / training

Selected by stratified partitioning

vascuCAP

Intervention Type DEVICE

time to event and phenotype classification model

Sequestered / test

Selected by stratified partitioning

vascuCAP

Intervention Type DEVICE

time to event and phenotype classification model

Interventions

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vascuCAP

time to event and phenotype classification model

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role collaborator

Elucid Bioimaging Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew J. Buckler, MS

Role: PRINCIPAL_INVESTIGATOR

Elucid Bioimaging Inc.

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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PoSTCARD

Identifier Type: -

Identifier Source: org_study_id

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