NCT01361659Unknown不适用
Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement of exercise tolerance
研究概览
简要总结
There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.
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
- •Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
- •Patients demonstrates exercise tolerance test (ETT) duration < 10 minutes on a modified Bruce protocol
- •No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
- •Patient's conditions stable for at least 3 months
- •Life expectancy of > 12 months.
排除标准
- •Unstable angina pectoris
- •Haemodynamically significant valvular heart disease
- •Myocardial infarction <3 month prior randomization
- •Evidence of intracardiac thrombus
- •Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
- •Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.
- •Patients who are unwilling or unable to cooperate with the study procedure.
- •Age < 18 years
- •Cardiac or pulmonary malignancy
- •No informed consent
- •Known depression
结局指标
主要结局
Improvement of exercise tolerance
时间窗: after 6 months
Modified Bruce protocol, changes compared to the baseline
次要结局
- Improvement of myocardial perfusion(6 months)
- Number of Patients with Adverse Events as a Measure of Safety(6 months)
- Improvement of quality of life(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Shockwave treatment for advanced angina in Maastricht (SWAAM). A double blind randomised study.chronic angina pectorisend stage coronary artery disease10011082NL-OMON36845Academisch Medisch Centrum55
已完成
1 期
Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina PectorisRefractory Angina PectorisNCT01219218Medispec33
已完成
2 期
Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIALAcute Coronary SyndromesNCT00225719CSL Limited180
已完成
不适用
Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 AntibodyAtherosclerosis of Coronary ArteryCoronary Artery DiseaseNCT04141579Radboud University Medical Center150
撤回
不适用
Radial Artery Spasm Leading to Occlusion in Patients Undergoing Coronary Angiogram Via Radial AccessArterial OcclusionArterial SpasmNCT02577796Antonios Likourezos