Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients having CEA | Patients undergoing carotid endarterectomy (CEA) for treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid endarterectomy | Procedure | (non-experimental) carotid endarterectomy (CEA) for treatment of carotid artery stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 1 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Columbia University/NY Presbyterian Hospital
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric J Heyer, M.D., Ph.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University, Department of Anesthesiology | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10727360 | Background | Parsson HN, Lord RS, Scott K, Zemack G. Maintaining carotid flow by shunting during carotid endarterectomy diminishes the inflammatory response mediating ischaemic brain injury. Eur J Vasc Endovasc Surg. 2000 Feb;19(2):124-30. doi: 10.1053/ejvs.1999.0954. | |
| 14580159 | Background | Jaranyi Z, Szekely M, Bobek I, Galfy I, Geller L, Selmeci L. Impairment of blood-brain barrier integrity during carotid surgery as assessed by serum S-100B protein concentrations. Clin Chem Lab Med. 2003 Oct;41(10):1320-2. doi: 10.1515/CCLM.2003.201. |
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Reference Group | Patients had "simple" spine surgery instead of Carotid endarterectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The mean and full range of the total is verified. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | Baseline to Day 1 |
|
11 years
All patients were examined with a battery of neuropsychometric tests before and after having carotid endarterectomy surgery.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Group | Patients had "simple" spine surgery instead of Carotid endarterectomy |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Other | Systematic Assessment | Stroke, which occurred in 12 patients. Stroke was defined as a new neurologic finding. |
Data for multiple time points (30 days) are inconclusive due to patient dropout. Data sets evolved between 1995-2012, and a master database linking subjects to publications was missing, obscuring sample derivation. Reported methods likely overstate neuropsychiatric testing completeness. Reasons for 'missingness' were multifactorial preventing assessment of impacts. Relevant journals were informed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric J Heyer | Columbia University | 212-305-9072 | ejh3@cumc.columbia.edu |
Not provided
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D002340 | Carotid Artery Diseases |
| D002546 | Ischemic Attack, Transient |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016894 | Endarterectomy, Carotid |
| ID | Term |
|---|---|
| D004691 | Endarterectomy |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
serum plasma DNA (via buccal samples will be obtained using a buccal cell collection swab)
| Neurological and neuropsychological evaluations | Other | Clinical examinations consisting of a neurological and neuropsychological evaluation |
|
| 9933278 | Background | Hetzel A, Braune S, Guschlbauer B, Dohms K. CO2 reactivity testing without blood pressure monitoring? Stroke. 1999 Feb;30(2):398-401. doi: 10.1161/01.str.30.2.398. |
| 9880393 | Background | Valdueza JM, Draganski B, Hoffmann O, Dirnagl U, Einhaupl KM. Analysis of CO2 vasomotor reactivity and vessel diameter changes by simultaneous venous and arterial Doppler recordings. Stroke. 1999 Jan;30(1):81-6. doi: 10.1161/01.str.30.1.81. |
| 9626280 | Result | Heyer EJ, Adams DC, Solomon RA, Todd GJ, Quest DO, McMahon DJ, Steneck SD, Choudhri TF, Connolly ES. Neuropsychometric changes in patients after carotid endarterectomy. Stroke. 1998 Jun;29(6):1110-5. doi: 10.1161/01.str.29.6.1110. |
| 23735728 | Result | Heyer EJ, Mergeche JL, Bruce SS, Connolly ES. Inflammation and cognitive dysfunction in type 2 diabetic carotid endarterectomy patients. Diabetes Care. 2013 Oct;36(10):3283-6. doi: 10.2337/dc12-2507. Epub 2013 Jun 4. |
| 23863764 | Result | Heyer EJ, Mergeche JL, Ward JT, Malone HR, Kellner C, Bruce SS, Connolly ES. Phosphodiesterase 4D single-nucleotide polymorphism 83 and cognitive dysfunction in carotid endarterectomy patients. Neurosurgery. 2013 Nov;73(5):791-6; discussion 796. doi: 10.1227/NEU.0000000000000085. |
| 23404722 | Result | Heyer EJ, Mergeche JL, Bruce SS, Ward JT, Stern Y, Anastasian ZH, Quest DO, Solomon RA, Todd GJ, Benvenisty AI, McKinsey JF, Nowygrod R, Morrissey NJ, Connolly ES. Statins reduce neurologic injury in asymptomatic carotid endarterectomy patients. Stroke. 2013 Apr;44(4):1150-2. doi: 10.1161/STROKEAHA.111.000362. Epub 2013 Feb 12. |
| 23662819 | Result | Heyer EJ, Kellner CP, Malone HR, Bruce SS, Mergeche JL, Ward JT, Connolly ES Jr. Complement polymorphisms and cognitive dysfunction after carotid endarterectomy. J Neurosurg. 2013 Sep;119(3):648-54. doi: 10.3171/2013.4.JNS1368. Epub 2013 May 10. |
| 26308635 | Derived | Heyer EJ, Mergeche JL, Wang S, Gaudet JG, Connolly ES. Impact of Cognitive Dysfunction on Survival in Patients With and Without Statin Use Following Carotid Endarterectomy. Neurosurgery. 2015 Dec;77(6):880-7. doi: 10.1227/NEU.0000000000000904. |
| 24995780 | Derived | Sussman ES, Kellner CP, Mergeche JL, Bruce SS, McDowell MM, Heyer EJ, Connolly ES. Radiographic absence of the posterior communicating arteries and the prediction of cognitive dysfunction after carotid endarterectomy. J Neurosurg. 2014 Sep;121(3):593-8. doi: 10.3171/2014.5.JNS131736. Epub 2014 Jul 4. |
| 24571940 | Derived | Halazun HJ, Mergeche JL, Mallon KA, Connolly ES, Heyer EJ. Neutrophil-lymphocyte ratio as a predictor of cognitive dysfunction in carotid endarterectomy patients. J Vasc Surg. 2014 Mar;59(3):768-73. doi: 10.1016/j.jvs.2013.08.095. |
| 24010976 | Derived | Heyer EJ, Mergeche JL, Connolly ES Jr. Middle cerebral artery pulsatility index and cognitive improvement after carotid endarterectomy for symptomatic stenosis. J Neurosurg. 2014 Jan;120(1):126-31. doi: 10.3171/2013.8.JNS13931. Epub 2013 Sep 6. |
| BG001 | Reference Group | Patients had "simple" spine surgery instead of Carotid endarterectomy |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Reference Group | Patients had spine surgery |
|
|
| 0 |
| 155 |
| 0 |
| 155 |
| 0 |
| 155 |
| EG001 | 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. | 0 | 662 | 0 | 662 | 12 | 662 |
|
Not provided
Not provided
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |