Neuropsychometric Outcome After Carotid Endarterectomy

NCT00597883 | Completed Results

• 1 other identifier: AAAA4811
• Study Type: observational
• Target: 817
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

carotid endarterectomy; Neuropsychological tests; Stroke; Transient ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients having CEA

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

Procedure: Carotid endarterectomy; Other: Neurological and neuropsychological evaluations

Interventions

Carotid endarterectomy PROCEDURE

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

Patients having CEA

Neurological and neuropsychological evaluations OTHER

Clinical examinations consisting of a neurological and neuropsychological evaluation

Patients having CEA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Columbia University/NY Presbyterian Hospital

You may qualify if:

• ability to speak English
• undergoing carotid endarterectomy procedure
• undergoing lumbar laminectomy procedure

You may not qualify if:

• history of permanent neurological impairment
• Axis I psychiatric diagnosis or drug abuse

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University, Department of Anesthesiology

New York, New York, 10032, United States

Location

Related Publications (13)

• 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.

  PMID: 10727360 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.

  PMID: 14580159 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.

  PMID: 9933278 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.

  PMID: 9880393 BACKGROUND

• 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.

  PMID: 9626280 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.

  PMID: 23735728 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.

  PMID: 23863764 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.

  PMID: 23404722 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.

  PMID: 23662819 RESULT

• 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.

  PMID: 26308635 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.

  PMID: 24995780 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.

  PMID: 24571940 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.

  PMID: 24010976 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum plasma DNA (via buccal samples will be obtained using a buccal cell collection swab)

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases; Ischemic Attack, Transient; Stroke

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

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.

Results Point of Contact

• Title: Eric J Heyer
• Organization: Columbia University

ejh3@cumc.columbia.edu

212-305-9072

Study Officials

• Eric J Heyer, M.D., Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: March 1, 2003
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 21, 2025
• Results First Posted: December 3, 2024

Record last verified: 2025-11

Locations

US (1)