Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Elucid Bioimaging Inc.
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Time to adverse outcome
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time to adverse outcome
Time Frame: >= 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.