N/A
N=125
Non-invasive Computer-Aided Phenotyping of Vasculopathy
Carotid Atherosclerosis · Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT02143102 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth. — -0.47; .07 mm2
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Elucid Bioimaging Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth. |
-0.47; .07 | — |
| PRIMARY Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth. |
1.26; .87 | — |
Summary
The investigators use MRI and/or CT to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care.
Eligibility Criteria
Inclusion Criteria
Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:
- Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study
- Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study
Exclusion Criteria
- Subjects with claustrophobia or inability to tolerate prior MRI studies.
- Subjects with metal implants that are not MRI compatible (LSU detailed checklist to be attached) including: Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- Subjects with a history of kidney disease or dialysis that are unable to receive intravenous gadolinium contrast material.
- Female subjects. A urine pregnancy test will be required of all female subjects of childbearing potential prior to inclusion in this study. Pregnant or nursing females will be excluded from the study.
- Subjects who cannot adhere to the experimental protocol.
- Subjects allergic to contrast material.
Data sourced from ClinicalTrials.gov (NCT02143102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.