NCT02014090已完成不适用
Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)
研究概览
简要总结
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External Counterpulsation (EECP) with regard to coronary collateral growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Age > 18 years, written informed consent to participate in the study
排除标准
- •Pregnancy (serum β-HCG<2 IU/l for all female volunteers)
- •Baseline History:
- •Endurance exercise 5 days before and the days between the exams
- •History of cardiovascular disease or surgery, including arterial hypertension, Raynaud phenomenon, recurrent migraine, or any cardiac rhythm disorder
- •History of metabolic disorder, particularly diabetes mellitus
- •History of respiratory, renal, hepatic or cerebral disease
- •Allergic reactions to Luminity or its components
- •Cardiovascular medication
- •Illness characterized by acute phase response
- •Anaemia with haemoglobin levels < 110 g/L
- •Baseline Physical Examination:
- •Peripheral artery disease
- •Baseline Echocardiogram:
- •Valvular heart disease
- •Aortic aneurysm (any abnormality of ascending aorta, aortic arch or descending aorta)
- •Intra- or extracardiac shunt
- •Systolic or diastolic left ventricular (LV) dysfunction
- •LV-hypertrophy
- •Pulmonary arterial hypertension
结局指标
主要结局
Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)
时间窗: During ECP respectively Bicycle Exercise, expected to be on average 90 minutes
次要结局
- Puls Wave Velocity Analysis(At baseline & post intervention, expected to be on average 90 minutes)
研究者
Christian Seiler
Prof Dr med
Insel Gruppe AG, University Hospital Bern
研究点 (2)
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