Non-invasive Computer-Aided Phenotyping of Vasculopathy

Completed

• Conditions: Carotid Atherosclerosis; Peripheral Arterial Disease

• Registration Number: NCT02143102
• Lead Sponsor: Elucid Bioimaging Inc.

Brief 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.

Detailed Description

The investigators hypothesize that in vivo MRI and/or CT examinations of patients, when suitably acquired and analyzed with the vascuCAP™ analysis software, can provide a sufficiently accurate profile of plaque characteristics to provide an objective basis for patient management. Study subjects include patients undergoing endarterectomies to mitigate their clinical risk or symptoms for conditions including stroke, claudication, and critical limb ischemia. The endarterectomy specimens removed at surgery will allow a direct comparison between the MRI information obtained prior to the surgery and the histopathological analyses of the arterial specimens. The vascuCAP™ measurements of structural and functional features of the arterial wall will be performed in patients undergoing endarterectomy. Measured results will be compared in a blinded fashion with histology to assess performance of plaque profiling and build a pilot prediction model for risk scoring.

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Study Start: 2014-07
• Primary Completion: 2017-03-14
• Study Completion: 2017-06-30
• Results First Submitted: 2017-09-07
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-07
• Last Update Submitted: 2017-11-07
• Results First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.	Assessed on tissue samples collected within 30 days of non-invasive imaging	Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.	Assessed on tissue samples collected within 30 days of non-invasive imaging	Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)

Trial Locations

Locations (2)

West Jefferson Medical Center; 🇺🇸 Marrero, Louisiana, United States

LSU ILH; 🇺🇸 New Orleans, Louisiana, United States