Impact of Del Nido Versus Blood Cardioplegia on Myocardial Viability Assessed With Magnetic Resonance Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Del Nido Cardioplegia Solution for myocardial protection, Blood Cardioplegia Solution for myocardial protection.
- Who it may be relevant to
- Registry conditions: CABG, Myocardial Viability. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Myocardial protection during surgical myocardial revascularization is crucial for reducing perioperative myocardial injury and improving postoperative outcomes. Blood cardioplegia represents the standard method in many centers, while del Nido cardioplegia, originally developed for the pediatric population, is increasingly being used in adult patients as well.
Detailed description
Previous studies have demonstrated reliable myocardial protection with Del Nido cardioplegia; however, most comparisons with conventional blood cardioplegia are based on biochemical markers (troponin, CK-MB) and echocardiography. Cardiac magnetic resonance imaging (CMR) enables noninvasive, highly sensitive assessment of left ventricular function as well as myocardial viability, edema, and fibrosis, and represents the gold standard for the evaluation of ventricular volumes and ejection fraction. To date, this imaging modality has not been used as a method for comparing different myocardial protection strategies in the context of various cardioplegic solutions.
The study will include patients with isolated coronary artery disease who are scheduled for surgical myocardial revascularization. Exclusion criteria will include the need for concomitant valve, aortic, or other cardiac surgery, as well as patients planned for myocardial revascularization without the use of cardiopulmonary bypass. Additionally, patients with contraindications to CMR will be excluded from the study.
Interventions
- Drug Del Nido Cardioplegia Solution for myocardial protection
CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy - Drug Blood Cardioplegia Solution for myocardial protection
Patients will receive Blood Cardioplegia Solution for myocardial protection
Primary outcome measures
- Myocardial Viability Assessed by Magnetic Resonance Imaging [Time frame: Patients will undergo the initial cardiac MRI scan before surgery. The follow-up MRI will be scheduled approximately 4 weeks after surgical revascularization.]
Secondary outcome measures (1)
- Major Adverse Cardiac and Cerebrovascular Events [Time frame: MACCE will be adjudicated at 30 days and 6 months.]
Eligibility criteria
Eligibility Criteria:
1\. Patients with multivessel coronary artery disease scheduled for elective coronary artery bypass grafting
Exclusion criteria
- Left ventricular ejection fraction <30%
- Associated cardiac procedures
- Off-pump coronary artery bypass grafting
- Contraindications for MRI
- Inability to provide consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Croatia · 2 centers
- University Hospital Center Zagreb — Zagreb
- University Hospital Center Zagreb — Zagreb
Identifiers
NCT: NCT07637266 · 02/013 DU