Neuropsychometric Outcome After Carotid Endarterectomy (CEA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT00597883
First received: January 9, 2008
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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
Carotid Artery Stenosis
Carotid Artery Disease
Transient Ischemic Attack
Stroke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurologic and Neuropsychometric Outcome in Patients Undergoing Carotid Endarterectomy

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Neuropsychometric Changes [ Time Frame: Baseline to 1 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychometric Changes [ Time Frame: Baseline to 1 Month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum plasma DNA (via buccal samples will be obtained using a buccal cell collection swab)


Estimated Enrollment: 600
Study Start Date: March 2003
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Columbia University/NY Presbyterian Hospital

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597883

Contacts
Contact: Kaitlin A Mallon, BA 212-305-8949 km2954@cumc.columbia.edu
Contact: Eric J Heyer, M.D., Ph.D. 212-305-9072 ejh3@columbia.edu

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric J. Heyer, MD, PhD, Professor of Clinical Anesthesiology, Columbia University
ClinicalTrials.gov Identifier: NCT00597883     History of Changes
Other Study ID Numbers: AAAA4811
Study First Received: January 9, 2008
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
carotid endarterectomy
Neuropsychological tests
Stroke
Transient ischemia

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

ClinicalTrials.gov processed this record on July 22, 2014