Neuropsychometric Outcome After Carotid Endarterectomy

NCT ID: NCT00597883

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 817 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2014-10-31

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

Conditions

Carotid Artery Stenosis; Carotid Artery Disease; Transient Ischemic Attack; Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients having CEA

Patients undergoing carotid endarterectomy (CEA) for treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations

Carotid endarterectomy

Intervention Type: PROCEDURE

(non-experimental) carotid endarterectomy (CEA) for treatment of carotid artery stenosis

Neurological and neuropsychological evaluations

Intervention Type: OTHER

Clinical examinations consisting of a neurological and neuropsychological evaluation

Interventions

Carotid endarterectomy

(non-experimental) carotid endarterectomy (CEA) for treatment of carotid artery stenosis

Intervention Type: PROCEDURE

Neurological and neuropsychological evaluations

Clinical examinations consisting of a neurological and neuropsychological evaluation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric J Heyer, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University, Department of Anesthesiology

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 9626280 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23735728 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10727360 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14580159 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9933278 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9880393 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23863764 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23404722 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23662819 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26308635 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24995780 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24571940 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24010976 (View on PubMed)

Other Identifiers

AAAA4811

Identifier Type: -

Identifier Source: org_study_id