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Non-invasive Computer-Aided Phenotyping of Vasculopathy (Q-CAMP)

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ClinicalTrials.gov Identifier: NCT02143102
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Carotid Atherosclerosis Peripheral Arterial Disease

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 Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: vascuCAP: Non-invasive Computer-Aided Phenotyping of Vasculopathy
Study Start Date : July 2014
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth. [ Time Frame: 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)

  2. Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth. [ Time Frame: 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)


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143102


Locations
United States, Louisiana
West Jefferson Medical Center
Marrero, Louisiana, United States, 70072
LSU ILH
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Elucid Bioimaging Inc.
Investigators
Study Director: Andrew J. Buckler, M.S. Elucid Biomaging Inc.
  Study Documents (Full-Text)

Documents provided by Elucid Bioimaging Inc.:
Informed Consent Form  [PDF] September 8, 2015


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elucid Bioimaging Inc.
ClinicalTrials.gov Identifier: NCT02143102     History of Changes
Other Study ID Numbers: 305
First Posted: May 20, 2014    Key Record Dates
Results First Posted: August 6, 2018
Last Update Posted: August 6, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Atherosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases