Carotid Atherosclerosis
Conditions
Brief summary
Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.
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.
Interventions
DIAGNOSTIC_TESTvascuCAP
adverse event and phenotype classification model
Sponsors
University of Maryland, College Park
Elucid Bioimaging Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse outcome model performance | 2 years | Develop adverse event model for major adverse neurological events (MANE) 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. |
Countries
United States
Contacts
Primary ContactAndrew J Buckler, MS
Outcome results
None listed