Neuropsychometric Outcome After Carotid Endarterectomy (CEA)

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. Identifier: NCT00597883
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : February 5, 2015
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University

Brief Summary:
The purpose of this study is to determine how well patients undergoing carotid endarterectomy will perform on a battery of tests to assess brain function before and after surgery as compared to a control group of patients undergoing spine surgery. This study will serve to: (a) determine incidence of neurologic/neuropsychometric change in patients undergoing carotid artery surgery, and (b) to ascertain the time it takes for these changes to resolve.

Condition or disease
Carotid Artery Stenosis Carotid Artery Disease Transient Ischemic Attack Stroke

Detailed Description:

Cerebral injury will be determined in four ways. First, all patients will be evaluated using a battery of neuropsychometric tests before and after surgery. Patients admitted to the Irving Clinical Research Center (CRC) will have their tests one day before, one day after surgery and at 1 month. Those coming into the hospital on the day of surgery, "Same Day", will be evaluated on the day of surgery, one day after and at the 1 month follow up. Preoperative neurological and neuropsychological evaluation will be performed. The neuropsychometric tests are not intended to be diagnostic of specific neuropsychiatric disorders, but rather are designed to demonstrate general neuropsychological pathology. These tests can be divided into four types: (1) an evaluation of language, (2) an evaluation of speed of mental processing, (3) an evaluation of ability to learn using a list of words, and (4) an evaluation of visual perception requiring a patient to copy a complex figure. Before the battery is administered we will assess each patient's level of pain while sitting and standing using a 10 point Visual Analog Scale and then gauge their mood with a series called the Wong/Baker Faces Rating scale.

We will be measuring Quality of Life (QOL) in all enrolled patients. This will be done using two well-known examinations (Telephone Interview for Cognitive Status (TICS) and Centers for Disease Control and Prevention Health-Related Quality of Life 14 Item Measure (CDC HRQOL14)) and a series of questions investigating how well patients are able to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). These tests will be given at two time points, once before the surgery and then one month after surgery. We will look for changes in quality of life that may correlate with neuropsychometric test performance.

Peripheral serum samples will be drawn before induction, before cross-clamping the carotid artery, 15 minutes after cross-clamping the carotid artery and 24 hours after surgery. These samples will be analyzed for four different sets of markers of cerebral injury, one gene and two markers of systemic inflammation. Serum levels of neuron specific enolase (NSE) and protein S100B, a neuronal enzyme and glial cell component respectively, markers of cell injury will demonstrate cerebral injury

Patients will undergo intraoperative TCD (Transcranial Doppler) The TCD examination will assess the brain's ability to increase cerebral blood flow in response to a pharmacological challenge (CO2 inhalation). TCD measures the degree of cerebral vasodilation, identified as an increase in flow velocity on TCD. This "cerebrovascular reserve" we hypothesize will be able to predict performance on postoperative neuropsychometric tests

Study Type : Observational
Actual Enrollment : 585 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurologic and Neuropsychometric Outcome in Patients Undergoing Carotid Endarterectomy
Study Start Date : March 2003
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Primary Outcome Measures :
  1. Neuropsychometric Changes [ Time Frame: Baseline to 1 Day ]

Secondary Outcome Measures :
  1. Neuropsychometric Changes [ Time Frame: Baseline to 1 Month ]

Biospecimen Retention:   Samples With DNA
serum plasma DNA (via buccal samples will be obtained using a buccal cell collection swab)

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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:   Non-Probability Sample
Study Population
Columbia University/NY Presbyterian Hospital

Inclusion Criteria:

  • ability to speak English
  • undergoing carotid endarterectomy procedure
  • undergoing lumbar laminectomy procedure

Exclusion Criteria:

  • history of permanent neurological impairment
  • Axis I psychiatric diagnosis or drug abuse

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 identifier (NCT number): NCT00597883

United States, New York
Columbia University, Department of Anesthesiology
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Eric J Heyer, M.D., Ph.D. Columbia University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eric J. Heyer, MD, PhD, Professor of Clinical Anesthesiology, Columbia University Identifier: NCT00597883     History of Changes
Other Study ID Numbers: AAAA4811
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Keywords provided by Eric J. Heyer, MD, PhD, Columbia University:
carotid endarterectomy
Neuropsychological tests
Transient ischemia

Additional relevant MeSH terms:
Carotid Artery Diseases
Carotid Stenosis
Ischemic Attack, Transient
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases