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Cognitive Outcome After Carotid Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02118233
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Carotid Stenosis

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.

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Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Outcome After Carotid Surgery
Study Start Date : April 2014
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019

Group/Cohort
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



Primary Outcome Measures :
  1. Measurement of change in cerebral blood flow from pre-op/baseline to 1 month post-operatively. [ Time Frame: 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 :
  1. Mini Mental Status Exam [ Time Frame: Pre-operative/baseline ]
    A standardized cognitive measure

  2. Trail Making- Part A [ Time Frame: 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

  3. Trail Making- Part B [ Time Frame: 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

  4. Hopkins Verbal Learning Test (HVLT) [ Time Frame: 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

  5. D-KEFS Verbal Fluency Test (FAS) [ Time Frame: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline ]
    Standardized measure to assess letter fluency



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118233


Locations
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United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
United States, New York
University of Buffalo Neurosurgery (UBNS)
Buffalo, New York, United States, 14203
StonyBrook
Stony Brook, New York, United States, 11794-8122
Sponsors and Collaborators
Lahey Clinic
Investigators
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Principal Investigator: Zoher Ghogawala, MD Lahey Clinic, Inc.
Publications:
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Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT02118233    
Other Study ID Numbers: 2013-009
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: March 2018
Keywords provided by Lahey Clinic:
carotid
stenosis
surgery
cognitive
unilateral
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases