Non-invasive Computer-Aided Phenotyping of Vasculopathy

NCT02143102 | Completed Results

• 1 other identifier: 305
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

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.

Conditions

Carotid Atherosclerosis; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.

  Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)

  Assessed on tissue samples collected within 30 days of non-invasive imaging

• Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.

  Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)

  Assessed on tissue samples collected within 30 days of non-invasive imaging

Study Arms (2)

Training set

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

Testing set

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• Subjects who cannot adhere to the experimental protocol.
• Subjects allergic to contrast material.

Sponsors & Collaborators

• Elucid Bioimaging Inc.: lead

Study Sites (2)

West Jefferson Medical Center

Marrero, Louisiana, 70072, United States

Location

LSU ILH

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

• Sheahan M, Ma X, Paik D, Obuchowski NA, St Pierre S, Newman WP 3rd, Rae G, Perlman ES, Rosol M, Keith JC Jr, Buckler AJ. Atherosclerotic Plaque Tissue: Noninvasive Quantitative Assessment of Characteristics with Software-aided Measurements from Conventional CT Angiography. Radiology. 2018 Feb;286(2):622-631. doi: 10.1148/radiol.2017170127. Epub 2017 Aug 31.

  PMID: 28858564 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

After endarterectomy during surgery, the excised plaque specimens will be sent to the hospital's pathology lab to be analyzed.

MeSH Terms

Conditions

Carotid Artery Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Andrew J. Buckler
• Organization: Elucid Bioimaging

andrew.buckler@elucidbio.com

978-468-0508

Study Officials

• Andrew J. Buckler, M.S.

  Elucid Biomaging Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 20, 2014
• Study Start: July 1, 2014
• Primary Completion: March 14, 2017
• Study Completion: June 30, 2017
• Last Updated: August 6, 2018
• Results First Posted: August 6, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)