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Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

E

Elucid Bioimaging

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: vascuCAP

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04439643
PoSTCARD

Details and patient eligibility

About

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

Full 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.

Enrollment

800 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

800 participants in 2 patient groups

Development / training
Description:
Selected by stratified partitioning
Treatment:
Device: vascuCAP
Sequestered / test
Description:
Selected by stratified partitioning
Treatment:
Device: vascuCAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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