Impact of Different Cardioplegia Solutions on Indicators of Myocardial Injury During Coronary Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorDamascus University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All consecutive patients undergoing elective primary coronary artery bypass grafting will be enrolled in this study.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
The intervention is the use of a specific cardioplegia solution for myocardial protection
Procedure/SurgeryThree different solutions will be used for myocardial protection in this study, and will be compared using markers of myocardial injury
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: St. Thomas' cardioplegiaActive comparator 1 intervention
Group B: Calafiore cardioplegiaActive comparator 1 intervention
Group C: del Nido cardioplegiaActive comparator 1 intervention
Trial outcomes
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 hours2
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 hours3
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 hoursLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Damascus University Cardiac Surgery Hospital Status unavailable Rawda, Damascus, Rif-dimashq GovernorateSyria
Sponsors and contacts
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Source ClinicalTrials.gov
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