Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

NCT06977230 | Recruiting

• 1 other identifier: RIPC-T2DM-CABG-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Postoperative 24-hour high-sensitivity Troponin T level

  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.

  24 hours after surgery

Secondary Outcomes (5)

• Incidence and severity of acute kidney injury

  Within 72 hours postoperatively

• Postoperative 48-hour high-sensitivity Troponin T level

  48 hours after surgery

• Postoperative 72-hour high-sensitivity Troponin T level

  72 hours after surgery

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

  0-72 hours after surgery

• Length of ICU and hospital stay

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

Other Outcomes (3)

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

  Within 72 hours after surgery

• Correlation between Troponin T levels and duration of ICU stay

  From ICU admission through ICU discharge

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

  Intraoperative period and up to 72 hours postoperatively

Study Arms (2)

Remote Ischemic Preconditioning Group

ACTIVE COMPARATOR

Patients randomized to this group will receive remote ischemic preconditioning (RIPC) prior to sternotomy. RIPC will be performed by inflating a blood pressure cuff on the upper limb to 200 mmHg for 5 minutes, followed by 5 minutes of deflation. This cycle will be repeated 5 times before the start of cardiopulmonary bypass.Assigned Intervention: Remote Ischemic Preconditioning

Procedure: Remote Ischemic Preconditioning

Control Group

NO INTERVENTION

Patients in the control group will undergo standard anesthetic and surgical care without the application of remote ischemic preconditioning.

Interventions

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

Remote Ischemic Preconditioning Group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (2)

Mugla Training and Research Hospital

Muğla, 48000, Turkey (Türkiye)

NOT YET RECRUITING

Mugla Training and Research Hospital

Muğla, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Myocardial Ischemia; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Melike Korkmaz Toker, Associate Professor

CONTACT

00905054747098; meltoker@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 18, 2025
• Study Start: May 26, 2025
• Primary Completion: July 30, 2025
• Study Completion: September 15, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

TU (2)