Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02143102
Status:
COMPLETED
Last Update Posted:
2018-08-06
First Post:
2014-05-15
Brief Title:
Non-invasive Computer-Aided Phenotyping of Vasculopathy
Sponsor:
Elucid Bioimaging Inc
Organization:
Elucid Bioimaging Inc
Study Overview
Official Title:
vascuCAP Non-invasive Computer-Aided Phenotyping of Vasculopathy
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Q-CAMP
Brief Summary:
The investigators use MRI andor 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
Detailed Description:
The investigators hypothesize that in vivo MRI andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None