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

NCT06841757 | Active Not Recruiting

• 1 other identifier: MD-342-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus; Diastolic Function

Keywords

Coronary artery bypass surgery; Diastolic function; Remote ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

• E/e' Ratio (Diastolic Function)

  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.

  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

Secondary Outcomes (6)

• 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

• 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

• 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

Study Arms (4)

Diabetic with Remote ischemic preconditioning

EXPERIMENTAL

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.

Behavioral: Remote ischemic preconditioning

Non diabetic with Remote ischemic preconditioning

EXPERIMENTAL

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

Behavioral: Remote ischemic preconditioning

Diabetic without Remote ischemic preconditioning

NO INTERVENTION

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

Non diabetic without Remote ischemic preconditioning

NO INTERVENTION

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

Interventions

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

Diabetic with Remote ischemic preconditioning; Non diabetic with Remote ischemic preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alzahraa Khalil Marie: lead

Study Sites (1)

Cairo university hospital

Cairo, Egypt

Location

Related Publications (1)

• Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

  PMID: 33309175 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ahmed Alagaty Ehsan Alagaty, Professor of anesthesia

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer in Cairo university

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 24, 2025
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)