The Effect of Hypoxic and Normoxic Cerebral Oximetry Levels on Cognitive Functions After Carotid Endarterectomy

NCT05652426 | Completed

• 1 other identifier: ISuidiye
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we investigated the effect of the capacity to cope with oxidative stress (oxidative stress response during and after clamping) in individuals with cerebral oximetry level between 40- 60 % and above 60 % and their effect on cognitive functions. Methods: In this retrospective study, patients who were scheduled for carotid endarterectomy, examined the MOCA tests before and after the operation and collected blood samples intraoperatively were included between January 2020-2021. The time periods specified below, blood samples were taken and serums were frozen at -80 celcius all this patients. Montreal cognitive function assessment test was applied before the operation, 24 hours and 7 days after the operation. Ten mililiters venous blood samples were collected to examine the status of basal neuron specific enolase, S100B, oxydative stress parameters (HAF-1 and DAF-1) at time intervals. Time intervals as follow: T1: Peripheral baseline measurements (blood will be taken from arterial blood sampling) + Cerebral Oxymeter levels + Montreal cognitive performance test + Modified Rankin Scale (mRS) T2: 1 minute before clamping (from peripheral and jugular vena blood sampling) + Cerebral Oxymeter levels T3: Before opening clamp(from peripheral and jugular vena blood sampling) + Cerebral Oxymeter levels T4: 24 hours after the procedure. (peripheral blood sampling) + Montreal cognitive performance test T5: 7 days after the operation. (peripheral blood sampling) + Montreal cognitive performance test + CO levels+ Modified Rankin Scale (mRS) Results: We found significantly positive corelation between cerebral oxymeter levels, oxydative stress parameters and cognitive performance tests in this six patient.

Conditions

Cerebral Hypoxia; Carotid Stenosis; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Serebral biomarkers

  To investigate the correlation of brain oxygenation with cerebral biomarkers in patients with two different basal rSO2 levels (41-60% rSO2 and above 60% rSO2) in carotid endarterectomy operations.

  7 day

Secondary Outcomes (2)

• Oxydative stress parameters

  7 day

• Cognitive function

  7 day

Study Arms (2)

Group 1

Basal cerebral oximetry levels between 41-60%

Group 2

Basal cerebral oximetry levels \> 61%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were scheduled for carotid endarterectomy, examined the MOCA (Montreal cognitive assesment )tests before and after the operation and collected blood samples intraoperatively .

You may qualify if:

• Patients who were scheduled for carotid endarterectomy, examined the MOCA (Montreal cognitive assesment )tests before and after the operation and collected blood samples intraoperatively were included between January 2020-2021.

You may not qualify if:

• Irregular diabetes mellitus
• Pregnancy
• Acute or chronic renal failure
• Liver failure
• History of previous carotid or brain trauma
• Vasculitis
• Thyroid diseases
• Adrenal insufficiency
• Patients who cannot perform cognitive function tests
• Anemia (below 10 g/dl)
• History of previous stroke in the last 6 months
• Patients with plegia in the dominant upper extremity
• Patients who will be shunted during the operation.
• Patients with vertebrobacillary arterial system or ring of Willis anomaly
• Presence of acute myocardial infarction.

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

İlknur Suidiye Yorulmaz

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (7)

• Heyer EJ, Sharma R, Rampersad A, Winfree CJ, Mack WJ, Solomon RA, Todd GJ, McCormick PC, McMurtry JG, Quest DO, Stern Y, Lazar RM, Connolly ES. A controlled prospective study of neuropsychological dysfunction following carotid endarterectomy. Arch Neurol. 2002 Feb;59(2):217-22. doi: 10.1001/archneur.59.2.217.

  PMID: 11843692 BACKGROUND

• Zhang HP, Ma XD, Chen LF, Yang Y, Xu BN, Zhou DB. Cognitive Function After Carotid Endarterectomy: Early Decline and Later Recovery. Turk Neurosurg. 2016;26(6):833-839. doi: 10.5137/1019-5149.JTN.13382-14.1.

  PMID: 27438617 BACKGROUND

• Kuzhuget R, Starodubtsev V, Ignatenko P, Starodubtseva A, Voroshilina O, Ruzankin P, Karpenko A. The role of stump pressure and cerebral oximetry in predicting ischaemic brain damage during carotid endarterectomy. Brain Inj. 2017;31(13-14):1944-1950. doi: 10.1080/02699052.2017.1347279. Epub 2017 Sep 5.

  PMID: 28872355 BACKGROUND

• Koh MY, Powis G. Passing the baton: the HIF switch. Trends Biochem Sci. 2012 Sep;37(9):364-72. doi: 10.1016/j.tibs.2012.06.004. Epub 2012 Jul 18.

  PMID: 22818162 BACKGROUND

• Schmid T, Zhou J, Brune B. HIF-1 and p53: communication of transcription factors under hypoxia. J Cell Mol Med. 2004 Oct-Dec;8(4):423-31. doi: 10.1111/j.1582-4934.2004.tb00467.x.

  PMID: 15601571 BACKGROUND

• Lee JW, Bae SH, Jeong JW, Kim SH, Kim KW. Hypoxia-inducible factor (HIF-1)alpha: its protein stability and biological functions. Exp Mol Med. 2004 Feb 29;36(1):1-12. doi: 10.1038/emm.2004.1.

  PMID: 15031665 BACKGROUND

• Hashimoto T, Shibasaki F. Hypoxia-inducible factor as an angiogenic master switch. Front Pediatr. 2015 Apr 24;3:33. doi: 10.3389/fped.2015.00033. eCollection 2015.

  PMID: 25964891 BACKGROUND

MeSH Terms

Conditions

Hypoxia, Brain; Carotid Stenosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carotid Artery Diseases; Cerebrovascular Disorders; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• İlknur S Yorulmaz

  Duzce University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)