The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Sur… (NCT06841757) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery Between Diabetic and Non-Diabetic Patients
Egypt40 participantsStarted 2025-01-01
Plain-language summary
This randomized controlled study aims to evaluate the effects of Remote Ischemic Preconditioning (RIPC) on diastolic function in patients undergoing coronary artery bypass grafting (CABG). The study will compare diabetic and non-diabetic patients to determine whether RIPC improves myocardial relaxation and reduces diastolic dysfunction, as assessed by the E/e' ratio at multiple time points during the surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All adult patients scheduled for elective isolated on-pump CABG surgery for two- to three-vessel coronary artery disease.
* Both males and females will be included.
* In the diabetic groups: Type II diabetes currently requiring and adhering to insulin therapy for at least the past 3 months
* During cardiopulmonary bypass, the temperature will range from 28-33°C using an esophageal temperature probe.
* Antegrade warm cardioplegia will be given by the cardiovascular perfusionist.
* Baseline diastolic function will be obtained preoperatively using transthoracic echocardiography done within the six months prior to the surgery
Exclusion Criteria:
* Combined CABG and valve surgery, emergency CABG.
* Type I diabetes, Type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months
* Peripheral vascular disease (PVD) affecting the upper limbs.
* Acute coronary syndrome (ACS); acute or recent myocardial infarction.
* Left ventricular ejection fraction ≤30%.
* Serious pulmonary disease necessitating oxygen supplementation or mechanical ventilation.
* Renal failure, defined as eGFR \< 30 mL/min/1.73 m² or requiring renal replacement therapy (dialysis).
* Liver failure, including Child-Pugh Class B or C cirrhosis, severe hepatocellular dysfunction, or listed for liver transplantation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
E/e' Ratio (Diastolic Function)
Timeframe: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU