NCT00597883|CompletedResults
Neuropsychometric Outcome After Carotid Endarterectomy
CEA
Neurologic and Neuropsychometric Outcome in Patients Undergoing Carotid Endarterectomy
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CEA
Neurologic and Neuropsychometric Outcome in Patients Undergoing Carotid Endarterectomy
Sponsor study identifier
observational
817
1 country
1
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
January 9, 2008
Actual (reported)January 18, 2008
Actual (reported)October 2014
Actual (reported)October 2014
Actual (reported)December 3, 2024
Actual (reported)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
Patients undergoing carotid endarterectomy (CEA) for treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations
(non-experimental) carotid endarterectomy (CEA) for treatment of carotid artery stenosis
Clinical examinations consisting of a neurological and neuropsychological evaluation
Columbia University/NY Presbyterian Hospital
Columbia University, Department of Anesthesiology
New York, New York, 10032, United States
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.
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.
serum plasma DNA (via buccal samples will be obtained using a buccal cell collection swab)
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.
Eric J Heyer, M.D., Ph.D.
Columbia University
817 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2008
First Posted
January 18, 2008
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
November 21, 2025
Results First Posted
December 3, 2024
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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