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Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250935
Recruitment Status : Active, not recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Ökkeş Hakan Miniksar, Bozok University

Brief 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.

Condition or disease Intervention/treatment
Cognitive Dysfunction Diagnostic Test: Patients with cognitive dysfunction

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Relationship Between Neurocognitive Changes and Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Postoperative cognitive dysfunction [ Time Frame: 4 days ]
    Relationship between serum brain-derived neurotrophic factor level and cognitive dysfunction



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Volunteer patients to be included in the study: 30 adult patients who will undergo coronary artery bypass grafting (CABG) surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250935


Locations
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Turkey
Bozok University Medical Center
Yozgat, Turkey
Sponsors and Collaborators
Bozok University
Investigators
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Study Director: Yozgat Bozok University Research Hospital Yozgat
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Responsible Party: Ökkeş Hakan Miniksar, Asist.Prof., Bozok University
ClinicalTrials.gov Identifier: NCT04250935    
Other Study ID Numbers: 20194466
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Can be announced after the work is completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders