Clinical trial NCT06841757: The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery Between Diabetic and Non-Diabetic Patients
Official title: Efficacy of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery: A Randomized Controlled Study Comparing Diabetic and Non-Diabetic Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Diabetes Mellitus
Diastolic Function
Keywords: Coronary artery bypass surgery
Diastolic function
Remote ischemic preconditioning
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: E/e' Ratio (Diastolic Function)
timeFrame: 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:
measure: Mitral Inflow Velocities(E/A Ratio)
timeFrame: 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
measure: Deceleration Time (DT)
timeFrame: 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
measure: Cardiac Troponin Levels
timeFrame: Evaluate cardiac troponin levels postoperatively after 24 hours as a marker of myocardial injury
measure: Systolic and diastolic Blood pressure
timeFrame: 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
measure: Inotropic Support:
timeFrame: During surgery
measure: LVEF
timeFrame: Compare between start and end of surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospital
Study officials:
affiliation: Cairo University
name: Ahmed Alagaty Ehsan Alagaty, Professor of anesthesia
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.