Coronary Artery Disease, Diabetes Mellitus, Diastolic Function
Conditions
Keywords
Coronary artery bypass surgery, Diastolic function, Remote ischemic preconditioning
Brief 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.
Interventions
BEHAVIORALRemote ischemic preconditioning
Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation
Sponsors
Alzahraa Khalil Marie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| E/e' Ratio (Diastolic Function) | 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 | Echocardiography (Tissue Doppler Imaging) will be used to measure the E/e' ratio, a reliable parameter for assessing left ventricular filling pressure and diastolic function. This is the primary method to evaluate the effect of Remote Ischemic Preconditioning (RIPC) on diastolic function in both diabetic and non-diabetic patients undergoing CABG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deceleration Time (DT) | 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 | — |
| Cardiac Troponin Levels | Evaluate cardiac troponin levels postoperatively after 24 hours as a marker of myocardial injury | — |
| Mitral Inflow Velocities(E/A Ratio) | 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 | Using TEE to measure E/A ratio |
| Inotropic Support: | During surgery | Usage and dose. |
| LVEF | Compare between start and end of surgery | Ejection fraction |
| Systolic and diastolic Blood pressure | 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 | — |
Countries
Egypt
Outcome results
None listed