Carotid StenosisNCT07843979
Perioperative GFAP and Neurological Complications After Carotid Endarterectomy
An observational study of Carotid Stenosis, run by Filiz Ata at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center observational study will evaluate whether blood levels of glial fibrillary acidic protein (GFAP), a protein associated with injury to supporting cells in the brain, are related to neurological complications after carotid endarterectomy. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Serum GFAP Measurement
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with carotid artery disease who are scheduled for elective isolated carotid endarterectomy and are treated at the Cardiovascular Surgery Clinic of Bursa Yuksek Ihtisas Training and Research Hospital.
Who may be able to join
- Age 35 to 90 years
- Scheduled to undergo elective isolated carotid endarterectomy
- Willing and able to provide informed consent and the required blood samples
Who cannot join
- Acute coronary syndrome within the previous 3 months
- Carotid endarterectomy planned in combination with another surgical procedure
- Atrial fibrillation
- Known inflammatory disease
- Hematologic disease
- Refusal to provide preoperative consent or a blood sample
- Stroke with residual neurological sequelae within the previous year
- Multiple sclerosis, Alzheimer disease, Parkinson disease, or another pre-existing neurological disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Bursa, 16310
Filiz Ata, +90 505 631 49 68, filizatafiliz@hotmail.com
Filiz Ata
About this study
Official title: Investigation of the Association Between Perioperative Glial Fibrillary Acidic Protein Levels and Postoperative Neurological Complications After Carotid Endarterectomy
This prospective, single-center observational study will evaluate whether blood levels of glial fibrillary acidic protein (GFAP), a protein associated with injury to supporting cells in the brain, are related to neurological complications after carotid endarterectomy. Adults aged 35 to 90 years undergoing elective isolated carotid endarterectomy will be enrolled. Serum GFAP will be measured before surgery and 24 hours after surgery. Investigators will record perioperative clinical information and postoperative neurological outcomes, including transient ischemic attack, stroke, delirium, and cognitive dysfunction. Approximately 90 participants are planned. The study will not assign any treatment or procedure.
Read the detailed description
Patients scheduled for elective isolated carotid endarterectomy at Bursa Yuksek Ihtisas Training and Research Hospital will be prospectively observed. Serum GFAP will be measured before surgery and 24 hours after surgery. Recorded variables will include demographic characteristics, comorbidities, coronary artery disease, echocardiographic and routine laboratory findings, perioperative anesthetic medications, hemodynamic measurements, peripheral oxygen saturation, and cerebral oxygenation measured by near-infrared spectroscopy (NIRS). Postoperative observations will include bleeding, hematoma, transient ischemic attack, stroke, delirium, cognitive dysfunction, and serum GFAP values. Analyses will compare participants who develop a postoperative neurological complication with those who do not and will evaluate the association of GFAP measurements with neurological complications using univariable and multivariable logistic regression. This is a non-interventional study; all clinical care will be determined by the treating team.
- Conditions
- Carotid Stenosis
- Being tested
- Serum GFAP Measurement
- Keywords
- Glial Fibrillary Acidic Protein, Carotid Endarterectomy, Postoperative Neurological Complications, Cerebral Oximetry
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum GFAP MeasurementDiagnostic test
Serum glial fibrillary acidic protein (GFAP) is measured before carotid endarterectomy and 24 hours after surgery. The measurements are collected for observational analysis and do not determine the participant's clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Endarterectomy Cohort | Adults undergoing elective isolated carotid endarterectomy. Serum GFAP is measured before surgery and 24 hours after surgery, and participants are observed for postoperative neurological complications. Receives: Diagnostic Test: Serum GFAP Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postoperative Neurological Complications
Number of participants who experience at least one postoperative neurological complication after carotid endarterectomy: transient ischemic attack, stroke, delirium, or cognitive dysfunction. A participant with more than one event will be counted once in this composite outcome.
Measured: At hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start15 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filiz Ata
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Filiz Ata, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Filiz Ata, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843979
- Sponsor's protocol ID
- GFAP-KEA-2025-01
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Association Between Perioperative Glial Fibrillary Acidic Protein Levels and Postoperative Neurological Complications After Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT07843979
- Acronym / sponsor ID
- GFAP-KEA-2025-01
- Conditions
- Carotid Stenosis
- Keywords
- Glial Fibrillary Acidic Protein, Carotid Endarterectomy, Postoperative Neurological Complications, Cerebral Oximetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Filiz AtaOther government
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Sep 2026 (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.
This prospective, single-center observational study will evaluate whether blood levels of glial fibrillary acidic protein (GFAP), a protein associated with injury to supporting cells in the brain, are related to neurological complications after carotid endarterectomy. Adults aged 35 to 90 years undergoing elective isolated carotid endarterectomy will be enrolled. Serum GFAP will be measured before surgery and 24 hours after surgery. Investigators will record perioperative clinical information and postoperative neurological outcomes, including transient ischemic attack, stroke, delirium, and cognitive dysfunction. Approximately 90 participants are planned. The study will not assign any treatment or procedure.
Detailed description
Patients scheduled for elective isolated carotid endarterectomy at Bursa Yuksek Ihtisas Training and Research Hospital will be prospectively observed. Serum GFAP will be measured before surgery and 24 hours after surgery. Recorded variables will include demographic characteristics, comorbidities, coronary artery disease, echocardiographic and routine laboratory findings, perioperative anesthetic medications, hemodynamic measurements, peripheral oxygen saturation, and cerebral oxygenation measured by near-infrared spectroscopy (NIRS). Postoperative observations will include bleeding, hematoma, transient ischemic attack, stroke, delirium, cognitive dysfunction, and serum GFAP values. Analyses will compare participants who develop a postoperative neurological complication with those who do not and will evaluate the association of GFAP measurements with neurological complications using univariable and multivariable logistic regression. This is a non-interventional study; all clinical care will be determined by the treating team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Endarterectomy Cohort | – | Diagnostic Test: Serum GFAP MeasurementAdults undergoing elective isolated carotid endarterectomy. Serum GFAP is measured before surgery and 24 hours after surgery, and participants are observed for postoperative neurological complications. |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with carotid artery disease who are scheduled for elective isolated carotid endarterectomy and are treated at the Cardiovascular Surgery Clinic of Bursa Yuksek Ihtisas Training and Research Hospital.
Key inclusion criteria (3 listed)
- Age 35 to 90 years
- Scheduled to undergo elective isolated carotid endarterectomy
- Willing and able to provide informed consent and the required blood samples
Key exclusion criteria (8 listed)
- Acute coronary syndrome within the previous 3 months
- Carotid endarterectomy planned in combination with another surgical procedure
- Atrial fibrillation
- Known inflammatory disease
- Hematologic disease
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 |
|---|---|---|
| Serum GFAP MeasurementSerum glial fibrillary acidic protein (GFAP) is measured before carotid endarterectomy and 24 hours after surgery. The measurements are collected for observational analysis and do not determine the participant's clinical care. | Diagnostic test | Carotid Endarterectomy Cohort |
Primary outcome
Number of Participants With Postoperative Neurological Complications
Time frame: At hospital discharge
Number of participants who experience at least one postoperative neurological complication after carotid endarterectomy: transient ischemic attack, stroke, delirium, or cognitive dysfunction. A participant with more than one event will be counted once in this composite outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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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.
Filiz Ata principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
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 Carotid Stenosis, run by Filiz Ata 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filiz Ata (+90 505 631 49 68, filizatafiliz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Neurological Complications (time frame: At hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026.