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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:
Exclusion Criteria:
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Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J. Buckler, M.S. | Elucid Biomaging Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Jefferson Medical Center | Marrero | Louisiana | 70072 | United States | ||
| LSU ILH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28858564 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Development Set | Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers. |
| FG001 | Testing Set | Data from subjects in the testing set will be used to assess the study endpoints. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Development Set | Data from subjects in the training set will be utilized to further develop the vascuCAP measurements. |
| BG001 | Testing Set | Data from subjects in the testing set will be used to assess the study endpoints. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | 95% Confidence Interval | mm2 | Assessed on tissue samples collected within 30 days of non-invasive imaging |
|
from time of enrollment through endarterectomy procedure, an average of 1 month
The study protocol was written to ensure that the study have no effect on either diagnosis or treatment of enrollees.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Development Set | Data from subjects in the training set will be utilized to further develop the vascuCAP measurements. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew J. Buckler | Elucid Bioimaging | 978-468-0508 | andrew.buckler@elucidbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2014 | Sep 7, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2015 | Sep 7, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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After endarterectomy during surgery, the excised plaque specimens will be sent to the hospital's pathology lab to be analyzed.
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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) | Posted | Mean | 95% Confidence Interval | mm2 | Assessed on tissue samples collected within 30 days of non-invasive imaging |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | Testing Set | Data from subjects in the testing set will be used to assess the study endpoints. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |