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

January 9, 2008
July 29, 2013
March 2003
March 2014   (final data collection date for primary outcome measure)
Neuropsychometric Changes [ Time Frame: Baseline to 1 Day ] [ Designated as safety issue: No ]
cognitive/neuropsychometric performance [ Time Frame: prior to surgery, 1 day post surgery, 1 month post surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00597883 on ClinicalTrials.gov Archive Site
Neuropsychometric Changes [ Time Frame: Baseline to 1 Month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Neuropsychometric Outcome After Carotid Endarterectomy
Neurologic and Neuropsychometric Outcome in Patients Undergoing Carotid Endarterectomy

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.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Columbia University/NY Presbyterian Hospital

  • Carotid Artery Stenosis
  • Carotid Artery Disease
  • Transient Ischemic Attack
  • Stroke
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United States
 
NCT00597883
AAAA4811
No
Eric J. Heyer, MD, PhD, Columbia University
Columbia University
Not Provided
Principal Investigator: Eric J Heyer, M.D., Ph.D. Columbia University
Columbia University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP