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
Last Update Posted : August 2, 2017
|Condition or disease|
|Carotid Atherosclerosis Peripheral Arterial Disease|
|Study Type :||Observational|
|Actual Enrollment :||128 participants|
|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|
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.
- Bias, precision, and reproducibility of plaque as assessed by MRI and/or CT analyzed by vascuCAP™ relative to histopathology as ground truth. [ Time Frame: Assessed on tissue samples collected within 30 days of MRI ]We use MRI and/or CT analyzed by vascuCAP™ 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 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 vascuCAPTM 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.
- Accuracy of plaque type characterization by MRI and/or CT analyzed by vascuCAP™ as compared to histopathology as ground truth [ Time Frame: Assessed on tissue samples collected within 30 days of MRI ]Classify the target lesion according to whether the analytes suggest it is not a plaque, or if it is, which of the 8 AHA types best fits the analyte profile. for each of the AHA types according to histopathology, we will report the frequency with which vascuCAPTM's classification agrees with histopathology.
Biospecimen Retention: Samples Without DNA
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
|United States, Louisiana|
|West Jefferson Medical Center|
|Marrero, Louisiana, United States, 70072|
|New Orleans, Louisiana, United States, 70112|
|Study Director:||Andrew J. Buckler, M.S.||Elucid Biomaging Inc.|