Tolerability of enhanced external counter pulsation to improve circulation in patients with vascular disease

Not Applicable

• Conditions: Coronary heart disease (CHD), sable angina pectoris with systemic atherosclerosis, constrictions and occlusions of the arterial vessels throughout the body, and therefore also peripheral arterial occlusion disorder (PAOD), Fontaine stage II.; Circulatory System; Coronary heart disease Peripheral arterial occlusion disorder

• Registration Number: ISRCTN15405726
• Lead Sponsor: Interdisziplinäre Gefäßzentrum Nord

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Last Update Posted: 6 January 2020
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified