NCT04250935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

January 30, 2020

Last Update Submit

December 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative cognitive dysfunction

    Relationship between serum brain-derived neurotrophic factor level and cognitive dysfunction

    4 days

Interventions

Mini Mental Test Those with a score below 21 points

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteer patients to be included in the study: 30 adult patients who will undergo coronary artery bypass grafting (CABG) surgery

You may qualify if:

  • At Least Primary School Graduates,
  • Not Using Drugs That May Affect Cognitive Functions,
  • No Alcohol Substance Use,
  • Without Psychiatric And Neurological Diseases

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bozok University Medical Center

Yozgat, Turkey (Türkiye)

Location

Related Publications (1)

  • Miniksar OH, Cicekcioglu F, Kilic M, Honca M, Miniksar DY, Gocmen AY, Kacmaz O, Oz H. Decreased brain-derived neurotrophic factor levels may predict early perioperative neurocognitive disorder in patients undergoing coronary artery bypass surgery: A prospective observational pilot study. J Clin Anesth. 2021 Aug;71:110235. doi: 10.1016/j.jclinane.2021.110235. Epub 2021 Mar 25.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Yozgat Bozok University Research Hospital

    Yozgat

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist.Prof.

Study Record Dates

First Submitted

January 30, 2020

First Posted

January 31, 2020

Study Start

January 15, 2020

Primary Completion

August 15, 2020

Study Completion

October 15, 2020

Last Updated

December 3, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Can be announced after the work is completed.

Locations