Pre- and Post-operative Brain MRI in Carotid Endarterectomy

NCT04029259 | Completed

• 1 other identifier: MR caput and CEA
• Study Type: observational
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carotid Artery Stenoses

Outcome Measures

Primary Outcomes (1)

• Brain lesions on MRI

  Lesions on brain MRI representing thromboembolic or hemorrhagic episodes

  30 days

Secondary Outcomes (1)

• Time from Transient Ischemic Attack (TIA) or minor stroke to surgery

  Days before surgery, maximum 6 months

Other Outcomes (1)

• Complications to carotid surgery

  Within 30 days after surgery

Interventions

Brain MRI DIAGNOSTIC_TEST

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..

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Indication for carotid surgery

You may not qualify if:

• Contraindications to MRI

Sponsors & Collaborators

• Oslo University Hospital: lead

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Toril Rabben, PhD

  Oslo University Hospital, Dep. of Vascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Vascular Surgery

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: July 23, 2019
• Study Start: January 1, 2005
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: July 23, 2019

Record last verified: 2019-07