Clinical trial NCT06977230: Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG
Official title: The Effect of Remote Ischemic Preconditioning on Myocardial Protection in Patients With Type 2 Diabetes Mellitus Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Double-Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Coronary Artery Bypass
Remote Ischaemic Conditioning
Keywords: High sensitive Troponin T
Diabetes mellitus Type 2
Coronary Artery Bypass
Myocardial Ischemia
Remote Ischemic Conditioning
Acute Kidney Injury
Cardioprotection
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative 24-hour high-sensitivity Troponin T level
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Incidence and severity of acute kidney injury
timeFrame: Within 72 hours postoperatively
measure: Postoperative 48-hour high-sensitivity Troponin T level
timeFrame: 48 hours after surgery
measure: Postoperative 72-hour high-sensitivity Troponin T level
timeFrame: 72 hours after surgery
measure: Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively
timeFrame: 0-72 hours after surgery
measure: Length of ICU and hospital stay
timeFrame: From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days
Other outcomes:
measure: Correlation between high-sensitivity Troponin T levels and maximum vasoactive-inotropic score (VIS)
timeFrame: Within 72 hours after surgery
measure: Correlation between Troponin T levels and duration of ICU stay
timeFrame: From ICU admission through ICU discharge
measure: Correlation between intraoperative maximum vasoactive-inotropic score (VIS) and postoperative myocardial injury
timeFrame: Intraoperative period and up to 72 hours postoperatively
Locations:
city: Mugla
country: Turkey
facility: Mugla Training and Research Hospital
city: Mugla
country: Turkey
facility: Mugla Training and Research Hospital
Study officials:
References: