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OpenTrials
Completed

NCT Number: NCT04439643

Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)

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

Completed

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vascuCAP

Device

time to event and phenotype classification model

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Elucid Bioimaging Inc.

Industry

Collaborators

  • Medical University of South Carolina

Registry information

Acronym: PoSTCARD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2020
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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