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Carotid Risk Prediction (CRISP) Consortium

E

Elucid Bioimaging

Status

Unknown

Conditions

Carotid Atherosclerosis

Treatments

Diagnostic Test: vascuCAP

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.

Full description

Develop adverse 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 information on events and interventions.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient quality as documented in the vascuCAP Reading Manual.
  • Atherosclerotic plaque must be visualized within the carotid artery.

Exclusion criteria

  • Subjects without visible plaque within the carotid artery
  • Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)

Trial design

800 participants in 2 patient groups

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

Trial contacts and locations

5

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Central trial contact

Andrew J Buckler, MS

Data sourced from clinicaltrials.gov

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