Cognitive DysfunctionNCT04250935
Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery
An observational study of Cognitive Dysfunction, run by Bozok University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Patients with cognitive dysfunction
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 15 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteer patients to be included in the study: 30 adult patients who will undergo coronary artery bypass grafting (CABG) surgery
Who may be able to join
- At Least Primary School Graduates,
- Not Using Drugs That May Affect Cognitive Functions,
- No Alcohol Substance Use,
- Without Psychiatric And Neurological Diseases
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Neurocognitive Changes and Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery
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.
Read the 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.
- Conditions
- Cognitive Dysfunction
- Being tested
- Patients with cognitive dysfunction
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with cognitive dysfunctionDiagnostic test
Mini Mental Test Those with a score below 21 points
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive dysfunction
Relationship between serum brain-derived neurotrophic factor level and cognitive dysfunction
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start15 Jan 2020
- Primary completion15 Aug 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ökkeş Hakan Miniksar, Bozok University
- Investigators
- Yozgat Bozok University Research Hospital, Study director, Yozgat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250935
- Sponsor's protocol ID
- 20194466
- Status last verified
- Dec 2020
- First submitted
- 30 Jan 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Can be announced after the work is completed.
Publications
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.
PubMed 33774438
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Neurocognitive Changes and Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT04250935
- Acronym / sponsor ID
- 20194466
- Conditions
- Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients to be included in the study: 30 adult patients who will undergo coronary artery bypass grafting (CABG) surgery
Key inclusion criteria (4 listed)
- At Least Primary School Graduates,
- Not Using Drugs That May Affect Cognitive Functions,
- No Alcohol Substance Use,
- Without Psychiatric And Neurological Diseases
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with cognitive dysfunctionMini Mental Test Those with a score below 21 points | Diagnostic test | – |
Primary outcome
Postoperative cognitive dysfunction
Time frame: 4 days
Relationship between serum brain-derived neurotrophic factor level and cognitive dysfunction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Derived from this study: PubMed 33774438Miniksar 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.
- Individual participant dataSharing planned: No. Can be announced after the work is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yozgat Bozok University Research Hospital study director
Yozgat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by Bozok University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive dysfunction (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.