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临床试验/NCT06266065
NCT06266065招募中不适用

Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia in Patients With Refractory Angina Pectoris

Clinical Hospital Centre Zagreb2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
2
主要终点
Impact of Coronary Sinus Reducer on Coronary Microcirculation

研究概览

简要总结

The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).

The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter < 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization
  • Signed informed consent

排除标准

  • Severely reduced systolic ejection fraction of the left ventricle (EF < 35 %)
  • Severe renal impairment (eGFR < 30ml/min/1.73m2)
  • Severe chronic obstructive pulmonary disease (GOLD D)
  • Contraindication for application of papaverine or regadenoson

结局指标

主要结局

Impact of Coronary Sinus Reducer on Coronary Microcirculation

时间窗: 2 and half years

Assessment of Coronary Flow Reserve and Index of Microcirculatory Resistance before and after Coronary Sinus Reducer implantation

次要结局

  • Myocardial Ischemia assessment(2 and half years)
  • Angina assessment(2 and half years)
  • Functional capacity assessment(2 and half years)

研究者

发起方
Clinical Hospital Centre Zagreb
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josko Bulum, MD, PhD

MD, PhD, Principal Investigator

Clinical Hospital Centre Zagreb

研究点 (2)

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