The Impact of Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve in the Absence of Epicardial Coronary Artery Stenoses: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change of myocardial perfusion reserve (MPR)
研究概览
简要总结
The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.
详细描述
This is a mono-center, prospective, single arm, pilot study designed to assess the feasibility of the "Cardiac Shock Wave Treatment" in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.
A total of 10 subjects will be enrolled in the study. All enrolled study subjects will be assessed for clinical follow-up at the following intervals: 5 and 14 weeks post CSWT procedure.
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 anginal chest pain that prompted a myocardial stress test (nuclear myocardial perfusion imaging, stress echocardiography, or perfusion CMR)
- •Evidence for stress-induced myocardial ischemia in this examination
- •Coronary angiogram showing absence of ≥30% stenosis of epicardial coronary arteries
排除标准
- •Participation in other clinical trials
- •age <18 years
- •Contraindications to under cMRI
- •Contraindications to adenosine (severe chronic obstructive pulmonary disease (COPD), asthma, atrioventricular block (AV block) > grade 1)
- •Left ventricular thrombus
- •Uncontrolled diabetes mellitus
- •Uncontrolled arterial hypertension,
- •Any other severe chronic illness such as liver or renal failure (glomerular filtration rate (GFR) < 45 ml/min), active neoplastic disease, history of myocardial infarction or coronary revascularization within the past three months
- •Patients with pacemaker or implanted cardioverter defibrillator
- •Patients after valve surgical replacement
- •Patients after interventional valve replacement or reconstruction (e.g. transfemoral aortic valve replacement or MitraClip implantation)
- •Pregnancy (a reliable method of contraception must be used for the entire duration of the study)
- •Fertile female participants who are capable of bearing children and who do not use a method of contraception that is medically approved by the health authority of the respective country
- •Missing capacity to consent
结局指标
主要结局
Change of myocardial perfusion reserve (MPR)
时间窗: 5 weeks
Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 5 weeks
次要结局
- Regional wall motion(14 weeks)
- Enddiastolic volume(14 weeks)
- Endsystolic volume(14 weeks)
- Stroke volume(14 weeks)
- Ejection fraction(14 weeks)
- Severity and frequency of angina(14 weeks)
- New York Heart Association (NYHA) class(14 weeks)
- Exercise capacity(14 weeks)
- Quality of life (SF-36)(14 weeks)
- New myocardial scarring or fibrotic changes(14 weeks)
- Myocardial edema(14 weeks)
- Myocardial hemorrhage(14 weeks)
- Scar extent(14 weeks)
- Diffuse fibrosis(14 weeks)