Q-CAMP: Non-invasive Computer-Aided Phenotyping of Vasculopathy
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
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
- 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)
Eligibility Criteria
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.
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.- 305
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
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
|
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
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 |
andrew.buckler@elucidbio.com |
- 305