NCT07034612Completed
Choroidal Changes During Cardiopulmonary Bypass
Effect of Pulsatile and Non-Pulsatile Cardiopulmonary Bypass Flow on Choroidal Circulation in Diabetic and Non-Diabetic Patients
Source: ClinicalTrials.gov · Last updated 27 Jun 2025
Brief summary (registry, in English)
This prospective observational study investigates the impact of pulsatile versus non-pulsatile cardiopulmonary bypass (CPB) flow on choroidal circulation in diabetic and non-diabetic patients undergoing elective coronary artery bypass grafting (CABG). A total of 104 patients aged 30 to 70 years will be included, with balanced distribution between diabetic and non-diabetic groups. Optical coherence tomography angiography (OCTA) will be performed preoperatively and at 1 month postoperatively to assess changes in choroidal vascularity. The primary objective is to determine whether the type of CPB flow affects choroidal microcirculation, particularly in diabetic patients. The findings may support more individualized perfusion strategies in patients at risk of ocular microvascular impairment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 102 (actual)
- First submitted
- 14 Jun 2025
- Start date
- 1 Jan 2023
- Primary completion date
- 1 Jan 2025
- Lead sponsor
- Samsun University
- Diseases
- Diabetic eye disease
- NCT number
- NCT07034612
What you commit to
- Study type: Observational
- Participants enrolled: 102
- From 1 Jan 2023 to the primary completion date, 1 Jan 2025
- 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.
Other illness
- Re-do or emergency cardiac surgery
- Unstable metabolic state or active infection
- Presence of significant cataract, vitreous hemorrhage, or tremor
Age
- Age \<30 or \>70 years
- Diabetes duration \<10 years (for diabetic group)
Other
- Contraindications to OCTA imaging
Who the study is looking for
- Age between 30 and 70 years
- Undergoing elective, first-time coronary artery bypass graft surgery (CABG)
- Stable metabolic status
- For diabetic group: history of diabetes mellitus for more than 10 years
- No significant ocular media opacity (e.g., cataract or vitreous hemorrhage)
- No tremor or condition interfering with OCTA imaging
- Aortic cross-clamp time ≤ 120 minutes
Age in the registry: 30 years to 70 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 |
|---|---|---|---|
| Samsun University Faculty of medicine Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.