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NCT Number: NCT06841757

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Diabetes Mellitus Diastolic Function Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischemic preconditioning

Behavioral

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

Primary outcomes

  1. E/e' Ratio (Diastolic Function)

    Time frame: 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 outcomes

  1. Mitral Inflow Velocities(E/A Ratio)

    Time frame: 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

  2. Deceleration Time (DT)

    Time frame: 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

  3. Cardiac Troponin Levels

    Time frame: Evaluate cardiac troponin levels postoperatively after 24 hours as a marker of myocardial injury

  4. Systolic and diastolic Blood pressure

    Time frame: 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

  5. Inotropic Support:

    Time frame: During surgery

    Usage and dose.

  6. LVEF

    Time frame: Compare between start and end of surgery

    Ejection fraction

Sponsors and collaborators

Lead sponsor

Alzahraa Khalil Marie

Other

Registry information

Official study title

Efficacy of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery: A Randomized Controlled Study Comparing Diabetic and Non-Diabetic Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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