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Not yet recruitingNCT07358221Cardioplegia2Updated Jan 22, 2026

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

An interventional study of The intervention is the use of a specific cardioplegia solution for myocardial protection in Coronary Artery Bypass Grafting (CABG) Surgery and Myocardial Protection, sponsored by Damascus University. Not yet recruiting at 1 site in Syria. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Damascus University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Bypass Grafting (CABG) Surgery
  • Myocardial Protection

Keywords

  • coronary surgery
  • cardioplegia
  • complement activation
  • myocardial injury
03

In context

Lead sponsor

Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients will be excluded from this study if they had suffered from previous myocardial infarction, had reduced or were undergoing combined or repeated surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • ProcedureThe 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From start of surgery and for 24 hours

  2. 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.

    Time frame: from start of surgery and for 24 hours

  3. 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.

    Time frame: From start of surgery and for 24 hours

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 23630629 ↗
  • 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. PubMed 26188824 ↗

Individual participant data

Plan to share: Yes — Data will be uploaded on (figshare) data repository site

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Information will be made available in March 2027 and will be available permanently

Access criteria: open to all

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2026; primary completion for Feb 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2026
First posted
Jan 22, 2026
StartEst.
Feb 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Jan 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07358221
Responsible party
Mohammad Bashar Izzat (Professor, Damascus University) — Principal investigator
First posted
Jan 22, 2026
Start date
Feb 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Jan 22, 2026

Study contacts

Mohamad B Izzat, FRCS(CTh)
Contact
mbizzat@damascusuniversity.edu.sy
+963943240820
Mohammad S Hamra, MD
Contact
mbizzat@gmail.com
+963949889467
Mohammad B Izzat, FRCS(CTh)
study chair · Damascus University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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