The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery Between Diabetic and Non-Diabetic Patients

Alzahraa Khalil Marie

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Diastolic Function; Diabetes Mellitus

Treatments: Behavioral: Remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06841757

MD-342-2024

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups

Diabetic with Remote ischemic preconditioning

Experimental group

Description:

Remote Ischemic Preconditioning (RIPC) 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.

Treatment:

Behavioral: Remote ischemic preconditioning

Non diabetic with Remote ischemic preconditioning

Experimental group

Description:

Remote Ischemic Preconditioning (RIPC) Non-diabetic patients who undergo Remote ischemic preconditioning using the same ischemia/reperfusion protocol as the diabetic group.

Treatment:

Behavioral: Remote ischemic preconditioning

Diabetic without Remote ischemic preconditioning

No Intervention group

Description:

Diabetic patients who receive standard care for CABG surgery without Remote ischemic preconditioning

Non diabetic without Remote ischemic preconditioning

No Intervention group

Description:

Non-diabetic patients who receive standard care for CABG surgery without RIPC.