NCT07661238Active, not recruiting
Effect of Minimally Invasive Extracorporeal Circulation on Optic Nerve Sheath Diameter and Stroke Incidence in Isolated Open Heart Surgery
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
This prospective randomized controlled trial compares the effects of Minimally Invasive Extracorporeal Circulation (MiECC) versus conventional cardiopulmonary bypass (CPB) on optic nerve sheath diameter (ONSD) and postoperative stroke incidence in adult patients undergoing isolated open heart surgery. ONSD will be measured by ultrasound at 7 predefined time points (T0-T6). Primary outcomes include perioperative ONSD changes and 30-day stroke incidence. Secondary outcomes include TIA, delirium (CAM-ICU), MoCA scores, ICU and hospital stay, AKI, and transfusion requirements.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 7 May 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Diseases
- Stroke
- NCT number
- NCT07661238
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Nov 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency or salvage surgery
Other illness
- Off-pump, revision, or combined cardiac surgery
- History of stroke or TIA within the last 6 months
- History of ocular trauma or surgery
- Renal or hepatic failure with risk of advanced encephalopathy
Lab values
- Left ventricular ejection fraction \<30%
Other
- Pre-existing neurological deficit
- Bilateral optic nerve pathology
- Intracranial mass or hydrocephalus
- Requirement for deep hypothermic circulatory arrest
- Alcohol or substance dependency
- Preoperative requirement for mechanical circulatory support
- Symptomatic or severe carotid artery stenosis (\>70%)
- Refusal to participate in the study
Who the study is looking for
- Age 18 to 80 years
- Scheduled for elective isolated open heart surgery
- Requires cardiopulmonary bypass
- Able to provide written informed consent
- Adequate ultrasonographic window for ONSD measurement
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.