Neuropsychometric Outcome After Carotid Endarterectomy

Stroke Clinical Trial

— CEA  

Official title:

Neurologic and Neuropsychometric Outcome in Patients Undergoing Carotid Endarterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597883
• Other study ID #: AAAA4811
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: February 4, 2015
• Start date: March 2003
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases
• Carotid Artery Stenosis
• Carotid Stenosis
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
United States	Columbia University, Department of Anesthesiology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Hetzel A, Braune S, Guschlbauer B, Dohms K. CO2 reactivity testing without blood pressure monitoring? Stroke. 1999 Feb;30(2):398-401. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2 — View Citation

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: 10.1 — View Citation

Járányi Z, Székely M, Bobek I, Gálfy I, Gellér 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. — View Citation

Pärsson 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. — View Citation

Valdueza JM, Draganski B, Hoffmann O, Dirnagl U, Einhäupl KM. Analysis of CO2 vasomotor reactivity and vessel diameter changes by simultaneous venous and arterial Doppler recordings. Stroke. 1999 Jan;30(1):81-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychometric Changes		Baseline to 1 Day
Secondary	Neuropsychometric Changes		Baseline to 1 Month