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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Del Nido cardioplegia | Active Comparator | CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy |
|
| Blood cardioplegia | Active Comparator | CABG patients receiving blood cardioplegia as the myocardial protection strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Del Nido Cardioplegia Solution for myocardial protection | Drug | CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Viability Assessed by Magnetic Resonance Imaging | Myocardial Viability Assessed by Magnetic Resonance Imaging | Patients will undergo the initial cardiac MRI scan before surgery. The follow-up MRI will be scheduled approximately 4 weeks after surgical revascularization. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events | The secondary outcome will be a composite of mortality, periprocedural myocardial infarction, stroke, and cardiac rehospitalization | MACCE will be adjudicated at 30 days and 6 months. |
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Eligibility Criteria:
1. Patients with multivessel coronary artery disease scheduled for elective coronary artery bypass grafting
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hrvoje Gasparovic, MD, PhD | Contact | +385 1 236 7529 | hrvoje.gasparovic@kbc-zagreb.hr |
| Name | Affiliation | Role |
|---|---|---|
| Hrvoje Gasparovic | Clinical Hospital Centre Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Center Zagreb | Recruiting | Zagreb | 10000 | Croatia |
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| Blood Cardioplegia Solution for myocardial protection | Drug | Patients will receive Blood Cardioplegia Solution for myocardial protection |
|
| University Hospital Center Zagreb | Recruiting | Zagreb | 10000 | Croatia |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000712134 | Del Nido cardioplegia solution |
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