Cognitive Outcome After Carotid Surgery

Carotid Stenosis Clinical Trial

Official title:

Cognitive Outcome After Carotid Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118233
• Other study ID #: 2013-009
• Status: Completed
• Start date: April 2014
• Est. completion date: November 2019

Study information

• Verified date: March 2018
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Stenosis

Locations

Country	Name	City	State
United States	University of Buffalo Neurosurgery (UBNS)	Buffalo	New York
United States	Lahey Clinic, Inc.	Burlington	Massachusetts
United States	StonyBrook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D; MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet. 2004 May 8;363(9420):1491-502. Erratum in: Lancet. 2004 Jul 31;364(9432):416. — View Citation

Rothwell PM, Goldstein LB. Carotid endarterectomy for asymptomatic carotid stenosis: asymptomatic carotid surgery trial. Stroke. 2004 Oct;35(10):2425-7. Epub 2004 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of change in cerebral blood flow from pre-op/baseline to 1 month post-operatively.	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.	preoperative/baseline and 1 month postoperative/from baseline
Secondary	Mini Mental Status Exam	A standardized cognitive measure	Pre-operative/baseline
Secondary	Trail Making- Part A	Standardized cognitive measure that assesses verbal fluency	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
Secondary	Trail Making- Part B	Standardized cognitive measure that assesses executive functioning	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
Secondary	Hopkins Verbal Learning Test (HVLT)	Standardized measure to assess new learning and memory	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
Secondary	D-KEFS Verbal Fluency Test (FAS)	Standardized measure to assess letter fluency	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline