Tolerability of external pulsation therapy by patients with existing symptomatic arterial vascular disease and its effect on microcirculation, kidney function and skeletal muscles at different therapeutic pressure levels

Interdisziplinäre Gefäßzentrum Nord0 个研究点目标入组 20 人开始时间: 2019年12月9日最近更新: 2020年1月6日

试验速览

暂无简介。

•1. Age = 18 years
•2. Generalised atherosclerosis with at least one diseased vessel section
•3. Coronary heart disease (CHD), stable angina pectoris with systemic atherosclerosis = PAOD Fontaine stages II–IVa
•4. Already treated with ASA + statin therapy for at least 3 months

•1. Abdominal aortic aneurysm > 4.5 cm
•2. Cardiac arrhythmias or atrial fibrillation
•3. Acute deep vein thrombosis of the lower limbs or vein thrombosis <3 months
•4. Cardiac insufficiency NYHA III + IV
•5. LVEF <20 per cent
•6. Dementia or severe cognitive function disturbances with inability to understand the meaning and context of the clinical study
•7. Spastic paralyses, hemiplegia or any other neurological-orthopaedic disorder that makes adequate treadmill measurements impossible
•8. Medium severe aortic valve insufficiency > II° + mitral valve insufficiency = III°
•9. Uncontrolled hypertension > 180/100 mmHg
•10. FEV1 <1.5 L
•11. Abnormal laboratory parameters at visit 1:
•11.1. Glomerular filtration rate (GFR) <30 ml/min/1.73 m2
•11.2. Haemoglobin <10 g/dl
•11.3. Serum liver enzymes (ASAT, ALAT, GGT) > 3x normal value
•12. Severe drug addiction, excepting stable nicotine abuse in the past six months
•13. Simultaneous participation in another clinical study, excepting non-interventional studies
•14. PAOD in stages 1 and IVb

发起方

Interdisziplinäre Gefäßzentrum Nord