Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214429
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-12-28
Brief Title:
Shear Wave Elastography for Carotid Atherosclerotic Plaques
Sponsor:
UPECLIN HC FM Botucatu Unesp
Organization:
UPECLIN HC FM Botucatu Unesp
Study Overview
Official Title:
Evaluation of Atherosclerotic Carotid Plaque Stiffness by Shear Wave Elastography Greyscale Median Magnetic Resonance Imaging and Histopathological Analysis Diagnostic Test Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
The goal of this prospective diagnostic accuracy cohort study is to compare the accuracy of carotid atherosclerotic plaques stiffness assessed by shear wave elastography SWE with greyscale median values GSM magnetic resonance imaging MRI and histopathological findings in patients with carotid atherosclerotic plaques causing stenosis above 50 symptomatic or not
The main question it aims to answer is is the plaque stiffness correlatable with GSM values MRI findings or histopathological findings Participants will be subjected to a vascular ultrasound study in which the SWE and GSM will be assessed The second imaging modality for stenosis confirmation will be MRI and patients with confirmed symptomatic stenosis above 50 or assymptomatic stenosis above 70 will be considered for surgery intervention endarterectomy or angioplasty Patients that undergo endarterectomy will have the carotid plaques subjected to a histopathological study The study will not arbitrate about the treatment decision
The main question it aims to answer is is the plaque stiffness correlatable with GSM values MRI findings or histopathological findings Participants will be subjected to a vascular ultrasound study in which the SWE and GSM will be assessed The second imaging modality for stenosis confirmation will be MRI and patients with confirmed symptomatic stenosis above 50 or assymptomatic stenosis above 70 will be considered for surgery intervention endarterectomy or angioplasty Patients that undergo endarterectomy will have the carotid plaques subjected to a histopathological study The study will not arbitrate about the treatment decision
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None