Q-CAMP: Non-invasive Computer-Aided Phenotyping of Vasculopathy

Sponsor
Elucid Bioimaging Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02143102
Collaborator
(none)
125
2
36
62.5
1.7

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jul 1, 2014
    Actual Primary Completion Date :
    Mar 14, 2017
    Actual Study Completion Date :
    Jun 30, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West Jefferson Medical Center Marrero Louisiana United States 70072
    2 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)

    More Information

    Publications

    None provided.
    Responsible Party:
    Elucid Bioimaging Inc.
    ClinicalTrials.gov Identifier:
    NCT02143102
    Other Study ID Numbers:
    • 305
    First Posted:
    May 20, 2014
    Last Update Posted:
    Aug 6, 2018
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Development Set Testing Set
    Arm/Group Description Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers. Data from subjects in the testing set will be used to assess the study endpoints.
    Period Title: Overall Study
    STARTED 97 28
    COMPLETED 86 28
    NOT COMPLETED 11 0

    Baseline Characteristics

    Arm/Group Title Development Set Testing Set Total
    Arm/Group Description Data from subjects in the training set will be utilized to further develop the vascuCAP measurements. Data from subjects in the testing set will be used to assess the study endpoints. Total of all reporting groups
    Overall Participants 86 28 114
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    66.2
    (11)
    66.6
    (10.1)
    66.4
    (10.7)
    Sex: Female, Male (Count of Participants)
    Female
    32
    37.2%
    17
    60.7%
    49
    43%
    Male
    54
    62.8%
    11
    39.3%
    65
    57%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    82
    95.3%
    25
    89.3%
    107
    93.9%
    Not Hispanic or Latino
    2
    2.3%
    3
    10.7%
    5
    4.4%
    Unknown or Not Reported
    2
    2.3%
    0
    0%
    2
    1.8%

    Outcome Measures

    1. Primary Outcome
    Title Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
    Description Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
    Time Frame Assessed on tissue samples collected within 30 days of non-invasive imaging

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Testing Set Full
    Arm/Group Description Data from subjects in the testing set will be used to assess the study endpoints. Pooled results for final estimation
    Measure Participants 28 114
    Mean (95% Confidence Interval) [mm2]
    -0.47
    .07
    2. Primary Outcome
    Title Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
    Description Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
    Time Frame Assessed on tissue samples collected within 30 days of non-invasive imaging

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Testing Set Full
    Arm/Group Description Data from subjects in the testing set will be used to assess the study endpoints. Pooled results for final estimation
    Measure Participants 28 114
    Mean (95% Confidence Interval) [mm2]
    1.26
    .87

    Adverse Events

    Time Frame from time of enrollment through endarterectomy procedure, an average of 1 month
    Adverse Event Reporting Description The study protocol was written to ensure that the study have no effect on either diagnosis or treatment of enrollees.
    Arm/Group Title Development Set Testing Set
    Arm/Group Description Data from subjects in the training set will be utilized to further develop the vascuCAP measurements. Data from subjects in the testing set will be used to assess the study endpoints.
    All Cause Mortality
    Development Set Testing Set
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/86 (0%) 0/28 (0%)
    Serious Adverse Events
    Development Set Testing Set
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/86 (0%) 0/28 (0%)
    Other (Not Including Serious) Adverse Events
    Development Set Testing Set
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/86 (0%) 0/28 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Andrew J. Buckler
    Organization Elucid Bioimaging
    Phone 978-468-0508
    Email andrew.buckler@elucidbio.com
    Responsible Party:
    Elucid Bioimaging Inc.
    ClinicalTrials.gov Identifier:
    NCT02143102
    Other Study ID Numbers:
    • 305
    First Posted:
    May 20, 2014
    Last Update Posted:
    Aug 6, 2018
    Last Verified:
    Nov 1, 2017