Cognitive Outcome After Carotid Surgery

NCT02118233 | Completed DMC

• 1 other identifier: 2013-009
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 3

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.

Conditions

Carotid Stenosis

Keywords

carotid; stenosis; surgery; cognitive; unilateral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mini Mental Status Exam

  Pre-operative/baseline

• Trail Making- Part A

  Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline

• Trail Making- Part B

  Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline

• Hopkins Verbal Learning Test (HVLT)

  Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline

• D-KEFS Verbal Fluency Test (FAS)

  Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline

Study Arms (3)

Carotid Endarterectomy (CEA)

Surgical Revascularization- Carotid Endarterectomy (CEA)

Carotid Angioplasty and Stenting (CAS)

Surgical Revascularization- Carotid Angioplasty and Stenting (CAS)

Control Group- Medical Management

Control Group- Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with unilateral, asymptomatic, significant carotid artery stenosis who are ≥18 years of age who do not present with past or current significant cerebrovascular and neuropsychological disease.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (3)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

University of Buffalo Neurosurgery (UBNS)

Buffalo, New York, 14203, United States

Location

StonyBrook

Stony Brook, New York, 11794-8122, United States

Location

Related 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. doi: 10.1016/S0140-6736(04)16146-1.

  PMID: 15135594 BACKGROUND

• Rothwell PM, Goldstein LB. Carotid endarterectomy for asymptomatic carotid stenosis: asymptomatic carotid surgery trial. Stroke. 2004 Oct;35(10):2425-7. doi: 10.1161/01.STR.0000141706.50170.a7. Epub 2004 Aug 26. No abstract available.

  PMID: 15331794 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zoher Ghogawala, MD

  Lahey Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 26, 2019

Record last verified: 2018-03

Locations

US (3)