Pre- and Post-operative Brain MRI in Carotid Endarterectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenoses
• Intervention / Treatment: Diagnostic test: Brain MRI

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 320

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Department of Vascular Surgery at Oslo University Hospital for carotid endarterectomy. International guidelines on indications for surgery are followed, and the majority of the patients have symptomatic carotid stenosis occluding > 70% of the lumen of the internal carotid artery. Patients characteristics and indications for surgery are registered

Description

Inclusion Criteria:

• Indication for carotid surgery

Exclusion Criteria:

• Contraindications to MRI

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain lesions on MRI	Lesions on brain MRI representing thromboembolic or hemorrhagic episodes	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications to carotid surgery	TIA, minor stroke, nerve damage	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Toril Rabben, PhD, Oslo University Hospital, Dep. of Vascular Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2005
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: July 21, 2019
• First Posted (ACTUAL): July 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 21, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: MR caput and CEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No