Non-invasive Computer-Aided Phenotyping of Vasculopathy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Carotid Atherosclerosis Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training set

Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers.

No interventions assigned to this group

Testing set

Data from subjects in the testing set will be used to assess the study endpoints.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No