Cognitive Outcome After Carotid Surgery

Completed

• Conditions: Carotid Stenosis

• Registration Number: NCT02118233
• Lead Sponsor: Lahey Clinic

Brief Summary

The purpose of this study is to understand how carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS) affect memory and thinking resulting in improving or worsening of thinking or memory. There have been many studies on this subject, some finding that certain patients gain improvement in their brain function and others might get worse. The goal of this study is to discover which patients are more likely to have improved cognitive functioning. Carotid endarterectomy (CEA) and percutaneous carotid angioplasty and stenting (CAS) are not investigational and are an accepted treatment for your condition. In addition, subjects that choose not to undergo surgery will also be included in this study.

Detailed Description

At the present time, large multi-center clinical trials support the use of carotid revascularization for symptomatic carotid stenosis and for asymptomatic carotid stenosis (greater than 60%) to prevent stroke. Guidelines supporting the use of carotid endarterectomy for asymptomatic stenosis are based largely on the Asymptomatic Carotid Atherosclerosis Study (ACAS) which reported a 47% relative risk reduction for ipsilateral stroke or death in patients randomized to surgery compared to best medical management over 5 years. These data were further substantiated by the recent publication of the Medical Research Council Asymptomatic Carotid Surgery (ACST) trial results (1); however, both trials estimated that at least 40 operative procedures were required to prevent a single disabling stroke or death in one patient after 5 years (2). These data underscore the importance of understanding the cognitive risks of carotid revascularization and developing strategies to limit factors that contribute to this risk especially in asymptomatic patients.

The purpose of this study is to better understand the effect of carotid revascularization (using either carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS)) on cognitive outcome by prospectively collecting cerebral blood flow data and cognitive testing data prior to and after carotid revascularization procedures.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Status Verified: 2018-03
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients with asymptomatic (defined as no symptoms in past 6 months) carotid stenosis
• Patients with hemodynamically significant carotid artery stenosis (according to CREST criteria: ≥ 60% by angiography, OR ≥ 70% by ultrasound, OR ≥ 80% by CTA or MRA)

Exclusion Criteria

• Patients with prior large vessel infarct
• Patients with intracranial stenosis
• Patients with major depression
• Patients with Alzheimer disease (clinically defined or Wechsler IQ <80)
• Patients who have had previous ipsilateral carotid surgery
• Patients with baseline dementia defined as: Mini-Mental Status Examination score < 21 OR Mini-Mental score ≥21 AND Baseline HVLT scores more than 3 standard deviations below normal or FAS scores more than 2 standard deviations below normal OR other clinical symptoms that were not as evident on direct cognitive assessment (e.g. sundowning, getting lost while driving).

Note: A control group would be comprised of about 15 patients who meet eligibility criteria as above, but elect to have their condition followed rather than undergo revascularization.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of change in cerebral blood flow from pre-op/baseline to 1 month post-operatively.	preoperative/baseline and 1 month postoperative/from baseline	Quantitative flow MRA studies will be performed pre-operative and postoperative for those undergoing carotid revascularization surgery. Those not undergoing surgery will have this test upon study enrollment and approximately 1 month from study enrollment date.

Secondary Outcome Measures

Name	Time	Method
Mini Mental Status Exam	Pre-operative/baseline	A standardized cognitive measure
D-KEFS Verbal Fluency Test (FAS)	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline	Standardized measure to assess letter fluency
Trail Making- Part A	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline	Standardized cognitive measure that assesses verbal fluency
Trail Making- Part B	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline	Standardized cognitive measure that assesses executive functioning
Hopkins Verbal Learning Test (HVLT)	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline	Standardized measure to assess new learning and memory

Trial Locations

Locations (3)

University of Buffalo Neurosurgery (UBNS); 🇺🇸 Buffalo, New York, United States

Lahey Clinic, Inc.; 🇺🇸 Burlington, Massachusetts, United States

StonyBrook; 🇺🇸 Stony Brook, New York, United States