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

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Disease; Diabetes Mellitus; Diastolic Function

• Registration Number: NCT06841757
• Lead Sponsor: Alzahraa Khalil Marie

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2025-01-01
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
Inotropic Support:	During surgery	Usage and dose.

Trial Locations

Locations (1)

Cairo university hospital; 🇪🇬 Cairo, Egypt