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NCT Number: NCT06977230

Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

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.

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Key information

Conditions

Diabetes Mellitus Acute Kidney Injury Cardiovascular Diseases Coronary Artery Bypass Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Remote Ischaemic Conditioning Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mugla Training and Research Hospital, Muğla, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Remote ischemic preconditioning

Procedure

Remote ischemic preconditioning (RIPC) will be performed after anesthesia induction and before surgical incision. A standard blood pressure cuff will be placed on the upper limb (without arterial cannulation), inflated to 200 mmHg for 5 minutes, and then deflated for 5 minutes. This cycle will be repeated five times prior to sternotomy. The procedure will be carried out under general anesthesia, ensuring patient blinding. No pharmacological agents are involved in this intervention

Primary outcomes

  1. Postoperative 24-hour high-sensitivity Troponin T level

    Time frame: 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 outcomes

  1. Incidence and severity of acute kidney injury

    Time frame: Within 72 hours postoperatively

  2. Postoperative 48-hour high-sensitivity Troponin T level

    Time frame: 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.

  3. Postoperative 72-hour high-sensitivity Troponin T level

    Time frame: 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.

  4. Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively

    Time frame: 0-72 hours after surgery

  5. Length of ICU and hospital stay

    Time frame: From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days

Other outcomes

  1. Correlation between high-sensitivity Troponin T levels and maximum vasoactive-inotropic score (VIS)

    Time frame: Within 72 hours after surgery

  2. Correlation between Troponin T levels and duration of ICU stay

    Time frame: From ICU admission through ICU discharge

  3. Correlation between intraoperative maximum vasoactive-inotropic score (VIS) and postoperative myocardial injury

    Time frame: Intraoperative period and up to 72 hours postoperatively

    The correlation between the maximum intraoperative VIS score and high-sensitivity Troponin T (hs-TnT) levels measured at 24, 48, and 72 hours postoperatively will be assessed. This outcome will evaluate whether intraoperative hemodynamic support requirement is associated with subsequent myocardial injury.

Study contacts

Contact information is provided by the study sponsor or research team.

Melike Korkmaz Toker, Associate Professor

CONTACT

[email protected]

00905054747098

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 18, 2025
Registry last updated
Jun 18, 2025

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

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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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