Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

Coronary Artery Disease Clinical Trial

— PoSTCARD  

Official title:

Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04439643
• Other study ID #: PoSTCARD
• Status: Completed
• Start date: February 5, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2023
• Source: Elucid Bioimaging Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• vascuCAP
time to event and phenotype classification model

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Elucid Bioimaging Inc.	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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