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临床试验/NCT07637266
NCT07637266招募中不适用

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

Klinički Bolnički Centar Zagreb1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligibility Criteria:
  • 1. Patients with multivessel coronary artery disease scheduled for elective coronary artery bypass grafting

排除标准

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

研究者

发起方
Klinički Bolnički Centar Zagreb
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hrvoje Gasparovic

Head, Department of Cardiac Surgery

Klinički Bolnički Centar Zagreb

研究点 (1)

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