Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

Elucid Bioimaging Inc.800 enrolled

Overview

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

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

800

Conditions

Coronary Artery Disease

Interventions

vascuCAPDEVICE

time to event and phenotype classification model

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: >= 2 years

Data from ClinicalTrials.gov

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