Impact of Different Cardioplegia Solutions on Indicators of Myocardial Injury During Coronary Surgery (Cardioplegia2)

January 14, 2026 updated by: Mohammad Bashar Izzat, Damascus University

Impact of Different Cardioplegia Solutions on Extracellular Vesicles-derived miRNAs, Complement System, and Neutrophil Extracellular Traps (NETs) as Indicators of Myocardial Injury During Coronary Artery Bypass Surgery

The aim of the present study is to investigate intra-operative changes in markers of myocardial injury during ischemia and reperfusion, comparing three methods of myocardial protection; St. Thomas' cold crystalloid cardioplegia, Calafiore warm blood cardioplegia, or modified del Nido cold blood cardioplegia in routine coronary artery bypass grafting procedures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thirty consecutive patients undergoing elective primary coronary artery bypass grafting will be enrolled in this study. Patients were excluded from this study if they had suffered from previous myocardial infarction, had reduced ejection fraction or were undergoing combined or repeated surgery. Patients will be randomly assigned to undergo surgery using one of three methods for myocardial protection: Group 1: St. Thomas' cold crystalloid cardioplegia (consisting of 750 ml of normal saline solution, 110 - 147 mmol/L of sodium chloride, . 16 - 20 mmol/L of potassium chloride, 16-32 mmol/L of magnesium chloride, 1.2-2.4 mmol/L of Calcium Chloride, 10 mmol/L of Sodium Bicarbonate). This solution will be administered as a 1-liter bolus at 3-4 degrees C following application of the aortic cross-clamp, and repeated as a 500 ml bolus if cross-clamp time extended beyond 30 minutes. Group 2: Calafiore intermittent antegrade warm blood cardioplegia (consisting of normothermic pump blood, potassium chloride 2 mEq/ml and magnesium sulfate 50%). This cardioplegic solution will be administered at 37 degrees C following application of the aortic cross-clamp and repeated after completion of each distal coronary anastomosis. • Group 3: Modified del Nido intermittent antegrade cold blood cardioplegic solution (consisting of 750 ml of lactated Ringer solution, 200 ml of pump blood, 13 ml of sodium bicarbonate 8.4%, 16 ml of mannitol 20%, 4 ml of magnesium sulfate 50%, 13 ml of lidocaine 2% and 13 ml of potassium chloride 2 mEq/ml). This solution will be administered as a 1-liter bolus at 3-4 degrees C following application of the aortic cross-clamp, and repeated as a 500 ml bolus if cross-clamp time extended beyond 60 minutes.

Collection of blood samples and myocardial biopsies:

Peripheral blood samples will be collected immediately prior to surgery, 15 minutes after removal of cross-clamp, and at 6 hours and 24 hours postoperatively. Myocardial biopsies (4-14 mg wet weight) will be taken using a Tru-cut needle from the apex of the left ventricle in every patient as follows: Biopsy 1: "Resting specimen", immediately after beginning of extracorporeal circulation. Biopsy 2: "Ischemic specimen", 30 minutes after application of the aortic cross-clamp. Biopsy 3: "Reperfusion specimen", 20 minutes following the removal of aortic cross-clamp. Each specimen will be immediately snap-frozen in liquid nitrogen (-185 degrees C) until processing.

Extracellular vesicles-derived miRNA (miR-499, miR-208b, miR-133a, EV-miR-1) will be measured, and release kinetics of EV-miRNAs will be determined and compared between the three groups, including correlation between EV-miRNA and cross-clamp time.

Complement system activation (sC5b-9, C5a, C3a) will be determined and compared between the three groups, including whether blood cardioplegia reduces complement activation and the relation between cardioplegia temperature and complement activation.

Neutrophil extracellular Traps (dsDNA) will be determined and compared between the three groups, including the effect of hypothermia on NETs formation.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Syria
    • Rif-dimashq Governorate
      • Damascus, Rif-dimashq Governorate, Syria, Rawda
        • Damascus University Cardiac Surgery Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All consecutive patients undergoing elective primary coronary artery bypass grafting will be enrolled in this study.

Exclusion Criteria:

  • Patients will be excluded from this study if they had suffered from previous myocardial infarction, had reduced ejection fraction or were undergoing combined or repeated surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: St. Thomas' cardioplegia
Intervention: Patients in this group will be managed with St. Thomas' cold crystalloid cardioplegia solution during surgery
Procedure: The intervention is the use of a specific cardioplegia solution for myocardial protection
Three different solutions will be used for myocardial protection in this study, and will be compared using markers of myocardial injury
Active Comparator: Calafiore cardioplegia
Patients in this group will be managed with Calafiore warm blood intermittent cardioplegia solution during surgery
Procedure: The intervention is the use of a specific cardioplegia solution for myocardial protection
Three different solutions will be used for myocardial protection in this study, and will be compared using markers of myocardial injury
Active Comparator: del Nido cardioplegia
Patients in this group will be managed with del Nido cold blood intermittent cardioplegia solution during surgery
Procedure: The intervention is the use of a specific cardioplegia solution for myocardial protection
Three different solutions will be used for myocardial protection in this study, and will be compared using markers of myocardial injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in extracellular vesicles-derived miRNAs as markers of myocardial injury
Time Frame: From start of surgery and for 24 hours
Extracellular vesicles-derived miRNA (miR-499, miR-208b, miR-133a, EV-miR-1) will be measured, and release kinetics of EV-miRNAs will be determined and compared between the three groups, including correlation between EV-miRNA and cross-clamp time.
From start of surgery and for 24 hours
Changes in complement system activation
Time Frame: from start of surgery and for 24 hours
Complement system activation (sC5b-9, C5a, C3a) will be determined and compared between the three groups, including whether blood cardioplegia reduces complement activation and the relation between cardioplegia temperature and complement activation.
from start of surgery and for 24 hours
Changes in neutrophil extracellular traps (NETs)
Time Frame: From start of surgery and for 24 hours
Neutrophil extracellular Traps (dsDNA) will be determined and compared between the three groups, including the effect of hypothermia on NETs formation.
From start of surgery and for 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Chair: Mohammad B Izzat, FRCS(CTh), Damascus University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cardioplegia2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be uploaded on (figshare) data repository site

IPD Sharing Time Frame

Information will be made available in March 2027 and will be available permanently

IPD Sharing Access Criteria

open to all

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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