Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus; Coronary Artery Bypass; Remote Ischaemic Conditioning

• Registration Number: NCT06977230
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

This randomized, double-blind, prospective clinical trial aims to investigate the effect of remote ischemic preconditioning (RIPC) on myocardial protection in patients with type 2 diabetes mellitus undergoing elective coronary artery bypass graft (CABG) surgery. Perioperative myocardial injury remains a significant concern during CABG, particularly in high-risk patients such as those with diabetes. RIPC is a low-cost, non-invasive intervention that may reduce myocardial damage by enhancing ischemic tolerance through intermittent limb ischemia.

Sixty patients aged 40-85 years with type 2 diabetes scheduled for isolated CABG will be randomized to either receive RIPC or standard care. RIPC will be applied through five cycles of upper limb cuff inflation and deflation prior to sternotomy. High-sensitivity troponin T levels will be measured at 24, 48, and 72 hours postoperatively to assess myocardial injury. Secondary outcomes include acute kidney injury (KDIGO classification), maximum vasoactive-inotropic score (VIS) during the first 72 postoperative hours, ICU and hospital length of stay. This study will provide insight into the cardioprotective role of RIPC in diabetic patients undergoing cardiac surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-05-26
• Primary Completion: 2025-07-30
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosed with type 2 diabetes mellitus and receiving medical treatment
• Scheduled for isolated elective coronary artery bypass graft (CABG) surgery
• American Society of Anesthesiologists (ASA) physical status class III or IV
• Age between 40 and 85 years

Exclusion Criteria

Emergency CABG surgery Reoperation (revision surgery) Left ventricular ejection fraction (LVEF) < 40% History of cardiac arrest or cardiogenic shock Pregnancy Clinically significant peripheral arterial disease affecting the upper limbs Hepatic dysfunction (bilirubin > 20 μmol/L or INR > 2.0) Renal failure (eGFR < 20 mL/min/1.73 m²) Ongoing treatment with glibenclamide or nicorandil (agents known to interfere with ischemic preconditioning mechanisms) Asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative 24-hour high-sensitivity Troponin T level	24 hours after surgery	Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 24 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 24th postoperative hour and analyzed using a standardized high-sensitivity Troponin T assay (reference range: 0-14 ng/L). The primary endpoint will be the mean hs-TnT concentration in each group.

Secondary Outcome Measures

Name	Time	Method
Length of ICU and hospital stay	From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days
Postoperative 48-hour high-sensitivity Troponin T level	48 hours after surgery	Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 48 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 48th postoperative hour and analyzed using a standardized high-sensitivity Troponin T assay (reference range: 0-14 ng/L). The primary endpoint will be the mean hs-TnT concentration in each group.
Postoperative 72-hour high-sensitivity Troponin T level	72 hours after surgery	Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 72 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 72th postoperative hour and analyzed using a standardized high-sensitivity Troponin T assay (reference range: 0-14 ng/L). The primary endpoint will be the mean hs-TnT concentration in each group.
Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively	0-72 hours after surgery
Incidence and severity of acute kidney injury	Within 72 hours postoperatively

Trial Locations

Locations (1)

Mugla Training and Research Hospital; 🇹🇷 Mugla, Turkey