Perioperative GFAP and Neurological Complications After Carotid Endarterectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-90
SponsorFiliz Ata

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 35 to 90 years

Scheduled to undergo elective isolated carotid endarterectomy

Willing and able to provide informed consent and the required blood samples

Disqualifiers

Acute coronary syndrome within the previous 3 months

Carotid endarterectomy planned in combination with another surgical procedure

Atrial fibrillation

Known inflammatory disease

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Serum GFAP Measurement

    Diagnostic 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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Carotid Endarterectomy Cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At hospital discharge

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Filiz Ata

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Sponsor institution