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

NCT07358221 | Not Yet Recruiting

• 1 other identifier: Cardioplegia2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Bypass Grafting (CABG) Surgery; Myocardial Protection

Keywords

coronary surgery; cardioplegia; complement activation; myocardial injury

Outcome Measures

Primary Outcomes (3)

• Changes in extracellular vesicles-derived miRNAs as markers of myocardial injury

  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

  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)

  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

Study Arms (3)

St. Thomas' cardioplegia

ACTIVE COMPARATOR

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

Calafiore cardioplegia

ACTIVE COMPARATOR

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

del Nido cardioplegia

ACTIVE COMPARATOR

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

Interventions

The intervention is the use of a specific cardioplegia solution for myocardial protection PROCEDURE

Three different solutions will be used for myocardial protection in this study, and will be compared using markers of myocardial injury

Calafiore cardioplegia; St. Thomas' cardioplegia; del Nido cardioplegia

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University Cardiac Surgery Hospital

Damascus, Rif-dimashq Governorate, Rawda, Syria

Location

Related Publications (2)

• Zhou X, Mao A, Wang X, Duan X, Yao Y, Zhang C. Urine and serum microRNA-1 as novel biomarkers for myocardial injury in open-heart surgeries with cardiopulmonary bypass. PLoS One. 2013 Apr 22;8(4):e62245. doi: 10.1371/journal.pone.0062245. Print 2013.

  PMID: 23630629 BACKGROUND

• Lai KB, Sanderson JE, Izzat MB, Yu CM. Micro-RNA and mRNA myocardial tissue expression in biopsy specimen from patients with heart failure. Int J Cardiol. 2015 Nov 15;199:79-83. doi: 10.1016/j.ijcard.2015.07.043. Epub 2015 Jul 13.

  PMID: 26188824 BACKGROUND

Study Officials

• Mohammad B Izzat, FRCS(CTh)

  Damascus University School of Medicine

  STUDY CHAIR

Central Study Contacts

Mohamad B Izzat, FRCS(CTh)

CONTACT

+963943240820; mbizzat@damascusuniversity.edu.sy

Mohammad S Hamra, MD

CONTACT

+963949889467; mbizzat@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Information will be made available in March 2027 and will be available permanently
• Access Criteria: open to all

Locations

SY (1)