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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04250935
Other study ID # 20194466
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2020
Est. completion date October 15, 2020

Study information

Verified date December 2020
Source Bozok University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In patients undergoing coronary artery bypass surgery, the relationship between neurocognitive changes seen in the early period and brain-induced neurotrophic factor serum levels will be investigated.


Description:

Although postoperative cognitive dysfunction (POKD) is the most common neurological complication in patients undergoing coronary artery bypass grafting (CABG) surgery, its pathophysiology is still not fully understood. However, the quality of this dysfunction has not been properly measured. In addition to clinical tests, biomarkers are often used to detect the presence of POKD. In this study, it was aimed to evaluate the relationship between intraoperative and postoperative brain-derived neurotrophic factor serum levels and POKD in patients undergoing CABG surgery. This prospective observational study is planned to include 30 adult patients aged 40-90 years. Patients with stroke history, neurodegenerative disease, seizure history, alcohol use, general anxiety, hearing deficit, unilateral carotid artery stenosis greater than 70%, and carotid artery bilateral stenosis greater than 50% will be excluded from the study. This study aimed to determine perioperative changes in serum brain-derived neurotrophic factor levels in patients undergoing CABG surgery.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date October 15, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria: - At Least Primary School Graduates, - Not Using Drugs That May Affect Cognitive Functions, - No Alcohol Substance Use, - Without Psychiatric And Neurological Diseases Exclusion Criteria: - Uneducated Patients, - Drug Users Who May Affect Cognitive Functions (Antipsychotic, Antidepressant), - Have Alcohol And Substance Use Disorders, - Those With A History Of Central Nervous System Disease That May Cause Cognitive Dysfunction (Such As Stroke, Neurodegenerative Disease, Seizure, General Anxiety), - Hearing Deficit, - Patients With Unilateral Carotid Artery Stenosis Greater Than 70% And Bilateral Stenosis Greater than 50% Carotid Artery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Patients with cognitive dysfunction
Mini Mental Test Those with a score below 21 points

Locations

Country Name City State
Turkey Bozok University Medical Center Yozgat

Sponsors (1)

Lead Sponsor Collaborator
Bozok University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative cognitive dysfunction Relationship between serum brain-derived neurotrophic factor level and cognitive dysfunction 4 days
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