NCT03516643已完成不适用
Improving Myocardial Perfusion in Refractory Angina. Extracorporeal Shockwave Myocardial Revascularization in a Large Prospective Cohort
University of Turin, Italy0 个研究点目标入组 122 人开始时间: 2009年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 主要终点
- Improvement of myocardial perfusion
研究概览
简要总结
This is a prospective cohort study to examine the efficacy of ESMR application in patients with refractory angina despite optimal medical therapy, not suitable for further PCI or CABG. Characteristics such as angina class scores (CCS class score), nitroglycerin consumption and hospitalization were compared at baseline and 1, 6 and 12 months after ESMR therapy. The effect on cardiac perfusion was assessed at 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of coronary artery disease;
- •refractory angina pectoris, defined as the persistence of a angina pectoris (Canadian Cardiovascular Society class ≥ 2) for more than 3 months, despite the use of optimal medical therapy (which included β blockers, calcium channel blockers, long-acting nitrates, ivabradine, ranolazine and trimetazidine, up-titrated to the maximal tolerated dose) and coronary disease not amenable for further revascularization (as determined by an interventional cardiologist and cardiac surgeon);
- •stable maximal medical therapy for at least 6 weeks;
- •stress-induced ischemia at baseline SPECT;
- •left ventricular ejection fraction higher than 40%;
- •age higher than 18 years.
排除标准
- •myocardial infarction or unstable angina in the previous 3 months,
- •acute myocarditis, pericarditis, left ventricular thrombus, cardiac malignancies, chronic pulmonary disease (including emphysema and pulmonary fibrosis), endocarditis
- •pregnancy
研究组 & 干预措施
Shockwave
Experimental
Extracorporeal Shockwave treatment on Ischemic Myocardium
干预措施: Extracorporeal Shockwave Myocardial Revascularization (Other)
结局指标
主要结局
Improvement of myocardial perfusion
时间窗: 6months after ESMR
Reduction in stress-induced ischemia at SPECT
次要结局
- Reduction of symptoms(1, 6, 12 months)
研究者
Gianluca Alunni
MD, Cardiologist
University of Turin, Italy
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