Carotid Artery Disease, Carotid Artery Stenosis, Stroke, Transient Ischemic Attack
Conditions
Keywords
carotid endarterectomy, Neuropsychological tests, Stroke, Transient ischemia
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.
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
Interventions
PROCEDURECarotid endarterectomy
(non-experimental) carotid endarterectomy (CEA) for treatment of carotid artery stenosis
Clinical examinations consisting of a neurological and neuropsychological evaluation
Sponsors
Columbia University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Having a Significant Change in Neuropsychometric Performance After Carotid Endarterectomy | Baseline to Day 1 | Neuropsychometric performance change is measured in Z-scores by compared to a reference group of elderly patients \> 60 years having simple spine surgery. The Z-scores were generated as follows. The mean and standard deviation (SD) of the change scores (neurocognitive performance after surgery minus neurocogntivie performance before surgery \[baseline\]) was calculated for the reference group of patients. The mean and SD from the reference group was used to generate Z-scores: The mean change score from the reference group of patients was subtracted from the change scores in for each CEA patient for each test and divided by the SD of the change scores of the reference group of patients. |
Countries
United States
Participant flow
Recruitment details
Patients having CEA surgery were recruited independently of patients in the reference group, who were having simple spine surgery. Therefore, the 155 patients having simple spine surgery were not double counted.
Participants by arm
| Arm | Count |
|---|---|
| CEA Patients Consecutive patients were enrolled who were having elective carotid endarterectomy. Performance in these patients were based on testing before and after CEA at two time points: one and thirty days after surgery. The difference in performance on a battery of neuropsychometric tests was scored by comparing the mean and standard deviation in the change scores to a reference consisting of patients having simple spine surgery defined as microdiskectomy or one or two level laminectomies lasting less than four hours, not requiring blood transfusions and not needing to be admitted to the intensive care unit. | 662 |
| Reference Group Patients had simple spine surgery instead of Carotid endarterectomy | 155 |
| Total | 817 |
Baseline characteristics
| Characteristic | CEA Patients | Total | Reference Group |
|---|---|---|---|
| Age, Customized Age | 72 years | 72 years | 71 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 42 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 602 Participants | 757 Participants | 155 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 18 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 10 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 52 Participants | 207 Participants | 155 Participants |
| Race (NIH/OMB) White | 578 Participants | 578 Participants | 0 Participants |
| Region of Enrollment United States | 662 participants | 817 participants | 155 participants |
| Sex: Female, Male Female | 232 Participants | 287 Participants | 55 Participants |
| Sex: Female, Male Male | 430 Participants | 530 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 155 | 0 / 662 |
| other Total, other adverse events | 0 / 155 | 12 / 662 |
| serious Total, serious adverse events | 0 / 155 | 0 / 662 |
Outcome results
Primary
Percentage of Patients Having a Significant Change in Neuropsychometric Performance After Carotid Endarterectomy
Neuropsychometric performance change is measured in Z-scores by compared to a reference group of elderly patients \> 60 years having simple spine surgery. The Z-scores were generated as follows. The mean and standard deviation (SD) of the change scores (neurocognitive performance after surgery minus neurocogntivie performance before surgery \[baseline\]) was calculated for the reference group of patients. The mean and SD from the reference group was used to generate Z-scores: The mean change score from the reference group of patients was subtracted from the change scores in for each CEA patient for each test and divided by the SD of the change scores of the reference group of patients.
Time frame: Baseline to Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CEA Patients | Percentage of Patients Having a Significant Change in Neuropsychometric Performance After Carotid Endarterectomy | 22 percentage of participants |
| Reference Group | Percentage of Patients Having a Significant Change in Neuropsychometric Performance After Carotid Endarterectomy | 4.5 percentage of participants |