Neuropsychometric Outcome After Carotid Endarterectomy



Status:Completed
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:March 2003
End Date:October 2014

Use our guide to learn which trials are right for you!

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

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
We found this trial at
1
site
?
mi
from
New York, NY
Click here to add this to my saved trials