Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-04-23 @ 3:50 AM
Study NCT ID:
NCT02436967
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2015-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Classification of Carotid Plaque With Computed Tomography With Fast kVp (Kilovolt Peak)-Switching Technique
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Classification of Carotid Plaque With Computed Tomography With Fast kVp-switching Technique: A Comparison With Histology and 3-Tesla MRI
Status:
COMPLETED
Status Verified Date:
2023-10
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:
Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA classification (American Heart Association)- comparison between histology and CT. The CT is performed with a fast kVp-switching dual energy technique.
To compare the ability to detect iodine contrast enhancement in the carotid plaque compared with 3T MRI with gadolinium.
To compare the ability to detect iodine contrast enhancement in the carotid plaque compared with 3T MRI with gadolinium.
Detailed Description:
Patients planned for CEA (carotid endarterectomy) due to carotid stenosis will be examined with one extra CT and MRI before surgery. The CEA specimen is stored in the BiKE-registry (a biobank of operated carotid plaque at the Karolinska Institute). In that registry the patients will be given a personal code which is used to identify the CT, MRI and histology data further on.
Approved by regional ethical review board in Stockholm and local radiation comity at Karolinska University Hospital Solna (Dnr K2435-2014). Informed consent from the participating patients.
Approved by regional ethical review board in Stockholm and local radiation comity at Karolinska University Hospital Solna (Dnr K2435-2014). Informed consent from the participating patients.
Study Oversight
Has Oversight DMC:
False
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?: