Impact of Del Nido Versus Blood Cardioplegia on Myocardial Viability Assessed With Magnetic Resonance Imaging

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Del Nido Cardioplegia Solution for myocardial protection
  CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy
• Препарат Blood Cardioplegia Solution for myocardial protection
  Patients will receive Blood Cardioplegia Solution for myocardial protection

Первичные конечные точки

• Myocardial Viability Assessed by Magnetic Resonance Imaging [Срок оценки: Patients will undergo the initial cardiac MRI scan before surgery. The follow-up MRI will be scheduled approximately 4 weeks after surgical revascularization.]

Вторичные конечные точки (1)

• Major Adverse Cardiac and Cerebrovascular Events [Срок оценки: MACCE will be adjudicated at 30 days and 6 months.]

Критерии участия

Eligibility Criteria:

1\. Patients with multivessel coronary artery disease scheduled for elective coronary artery bypass grafting

Критерии исключения

• Left ventricular ejection fraction <30%
• Associated cardiac procedures
• Off-pump coronary artery bypass grafting
• Contraindications for MRI
• Inability to provide consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Хорватия · 2 центра

• University Hospital Center Zagreb — Zagreb
• University Hospital Center Zagreb — Zagreb

Идентификаторы

NCT: NCT07637266 · 02/013 DU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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