Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Development / training Selected by stratified partitioning
  • Diagnostic Test: vascuCAP
    adverse event and phenotype classification model
Sequestered / test Selected by stratified partitioning
  • Diagnostic Test: vascuCAP
    adverse event and phenotype classification model

Recruiting Locations

University of Maryland, Baltimore
Baltimore, Maryland 21201
Contact:
Brajesh K Lal, MD
410-328-5840
blal@som.umaryland.edu

Baltimore VA Medical Center
Baltimore, Maryland 21201
Contact:
Brajesh K Lal, MD
410-328-5840
blal@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
Elucid Bioimaging Inc.

Study Contact

Andrew J Buckler, MS
9784731986
andrew.buckler@elucidbio.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.