Coronary Artery Bypass Grafting (CABG) SurgeryCardioplegia2NCT07358221
Impact of Different Cardioplegia Solutions on Indicators of Myocardial Injury During Coronary Surgery
A study testing The intervention is the use of a specific cardioplegia solution for myocardial protection in people with Coronary Artery Bypass Grafting (CABG) Surgery and Myocardial Protection, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Bypass Grafting (CABG) Surgery, Myocardial Protection
- What is being tested?
- The intervention is the use of a specific cardioplegia solution for myocardial protection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients undergoing elective primary coronary artery bypass grafting will be enrolled in this study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syria1 site
Damascus University Cardiac Surgery Hospital
Damascus, Rif-dimashq Governorate, Rawda
About this study
Official title: 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.
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.
- Being tested
- The intervention is the use of a specific cardioplegia solution for myocardial protection
- Keywords
- coronary surgery, cardioplegia, complement activation, myocardial injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention is the use of a specific cardioplegia solution for myocardial protectionProcedure or surgery
Three different solutions will be used for myocardial protection in this study, and will be compared using markers of myocardial injury
| Study group | Role | What they receive |
|---|---|---|
| St. Thomas' cardioplegia | Active comparator | Intervention: Patients in this group will be managed with St. Thomas' cold crystalloid cardioplegia solution during surgery Receives: 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 Receives: 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 Receives: Procedure: The intervention is the use of a specific cardioplegia solution for myocardial protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From start of surgery and for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Grafting (CABG) SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Bashar Izzat, Damascus University
- Investigators
- Mohammad B Izzat, FRCS(CTh), Study chair, Damascus University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358221
- Sponsor's protocol ID
- Cardioplegia2
- Acronym
- Cardioplegia2
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded on (figshare) data repository site
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 23630629Lai 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07358221
- Acronym / sponsor ID
- Cardioplegia2 / Cardioplegia2
- Keywords
- coronary surgery, cardioplegia, complement activation, myocardial injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| St. Thomas' cardioplegia | Active comparator | Procedure: The intervention is the use of a specific cardioplegia solution for myocardial protectionIntervention: Patients in this group will be managed with St. Thomas' cold crystalloid cardioplegia solution during surgery |
| Calafiore cardioplegia | Active comparator | Procedure: The intervention is the use of a specific cardioplegia solution for myocardial protectionPatients in this group will be managed with Calafiore warm blood intermittent cardioplegia solution during surgery |
| del Nido cardioplegia | Active comparator | Procedure: The intervention is the use of a specific cardioplegia solution for myocardial protectionPatients in this group will be managed with del Nido cold blood intermittent cardioplegia solution during surgery |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients undergoing elective primary coronary artery bypass grafting will be enrolled in this study.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intervention is the use of a specific cardioplegia solution for myocardial protectionThree different solutions will be used for myocardial protection in this study, and will be compared using markers of myocardial injury | Procedure or surgery | Calafiore cardioplegia, St. Thomas' cardioplegia, del Nido cardioplegia |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 23630629Zhou 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.
- Background: PubMed 26188824Lai 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.
- Individual participant dataSharing planned: Yes. Data will be uploaded on (figshare) data repository site
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad B Izzat, FRCS(CTh) study chair
Damascus University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention is the use of a specific cardioplegia solution for myocardial protection in people with Coronary Artery Bypass Grafting (CABG) Surgery and Myocardial Protection, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad B Izzat, FRCS(CTh) (+963943240820, mbizzat@damascusuniversity.edu.sy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in extracellular vesicles-derived miRNAs as markers of myocardial injury (time frame: From start of surgery and for 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358221, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.