Trial Outcomes & Findings for Neuropsychometric Outcome After Carotid Endarterectomy (NCT NCT00597883)
NCT ID: NCT00597883
Last Updated: 2025-11-21
Results Overview
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.
COMPLETED
817 participants
Baseline to Day 1
2025-11-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Reference Group
Patients had "simple" spine surgery instead of Carotid endarterectomy
|
|---|---|---|
|
Overall Study
STARTED
|
662
|
155
|
|
Overall Study
COMPLETED
|
662
|
155
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuropsychometric Outcome After Carotid Endarterectomy
Baseline characteristics by cohort
| Measure |
CEA Patients
n=662 Participants
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.
|
Reference Group
n=155 Participants
Patients had "simple" spine surgery instead of Carotid endarterectomy
|
Total
n=817 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
72 years
n=68 Participants
|
71 years
n=76 Participants
|
72 years
n=48 Participants
|
|
Sex: Female, Male
Female
|
232 Participants
n=68 Participants
|
55 Participants
n=76 Participants
|
287 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
430 Participants
n=68 Participants
|
100 Participants
n=76 Participants
|
530 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
42 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
18 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
602 Participants
n=68 Participants
|
155 Participants
n=76 Participants
|
757 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
4 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
18 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
578 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
578 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
10 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=68 Participants
|
155 Participants
n=76 Participants
|
207 Participants
n=48 Participants
|
|
Region of Enrollment
United States
|
662 participants
n=68 Participants
|
155 participants
n=76 Participants
|
817 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 1Neuropsychometric 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.
Outcome measures
| Measure |
CEA Patients
n=662 Participants
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.
|
Reference Group
n=155 Participants
Patients had spine surgery
|
|---|---|---|
|
Percentage of Patients Having a Significant Change in Neuropsychometric Performance After Carotid Endarterectomy
|
22 percentage of participants
|
4.5 percentage of participants
|
Adverse Events
Reference Group
CEA Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference Group
n=155 participants at risk
Patients had "simple" spine surgery instead of Carotid endarterectomy
|
CEA Patients
n=662 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/155 • 11 years
All patients were examined with a battery of neuropsychometric tests before and after having carotid endarterectomy surgery.
|
1.8%
12/662 • Number of events 12 • 11 years
All patients were examined with a battery of neuropsychometric tests before and after having carotid endarterectomy surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place