Pre- and Post-operative Brain MRI in Carotid Endarterectomy

Carotid Artery Stenoses Clinical Trial

Official title:

Evaluation of Pre- and Post-operative Brain MRI in Carotid Endarterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029259
• Other study ID #: MR caput and CEA
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients undergoing carotid endarterectomy in the Department of Vascular Surgery at Oslo University Hospital are consecutively included in this evaluation og pre- and postoperative brain MRI.

Description:

Patients undergoing surgery for carotid stenosis in our Department are examined by brain MRI before and after carotid surgery to evaluate the rationale for the MRI. Brain lesions on MRI before and after carotid surgery are registered, and related to clinical findings. The purpose of the study is to evaluate whether brain MRI in relation to carotid endarterectomy gives additional information to clinical findings, and to CT scan of the brain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Indication for carotid surgery

Exclusion Criteria:

• Contraindications to MRI

Related Conditions & MeSH terms

• Carotid Artery Stenoses
• Carotid Stenosis

Intervention

Diagnostic Test:
• Brain MRI
Brain MRI diagnoses tromboembolic lesions or bleeding to the cerebrum and is part of preoperative diagnostic tests before carotid surgery. After surgery brain MRI may present New lesions related to surgery, clinically significant or insignificant. Our goal is to evaluate the relevance of this modality in carotid surgery..

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications to carotid surgery	TIA, minor stroke, nerve damage	Within 30 days after surgery
Primary	Brain lesions on MRI	Lesions on brain MRI representing thromboembolic or hemorrhagic episodes	30 days
Secondary	Time from Transient Ischemic Attack (TIA) or minor stroke to surgery	International guidelines recommends surgery within 14 days after TIA	Days before surgery, maximum 6 months