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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15405726

Enrollment

Registered

2019-12-09

Start date

2019-10-01

Completion date

Unknown

Last updated

2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Here we test the effect of low pressure external pulsation therapy (100 - 160 mmHg) in comparision to high pressure external pulsation therapy (250 - 280 mmHg) on 20 patients suffering from systemic a

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 II° + mitral valve insufficiency = III° 9. Uncontrolled hypertension > 180/100 mmHg 10. FEV1 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

Design outcomes

Primary

Measure	Time frame
Quality of Life measured using German IGZ Quality of Life Standard Questionnaire at baseline (visit 2), visit 3, and visit 4	—

Secondary

Measure	Time frame
Measured at Visit 2 (baseline), 3rd and 5th days in the first therapy phase of the study, 1st 3rd and 5th day of the second therapy phase and Visit 4 (3 days post last intervention). 1. O2C measurement under external counterpulsation therapy treatment measured using LEA Medizintechnik Giesen (Units and % oxygen) 2. Changes to perfusion of tissue (blood flow verlocity, blood filling of micro vessels, capillary sinus oxygen saturation) 3. Serum: 3.1. Creatinine (mg/dl) using the enzymatic method 3.2. Urea (mg/dl) using photometry 3.3. LDH (U/I) using photometry 3.4. Myoglobin (µg/l) using Sandwich Immunoassay 3.5. Creatine Kinase (g/g) using the enzymatic method 3.6. Potassium(mmol/l) using ion-selective electrode (ISE) 3.7. Lactate (mmol/l) using photometry 4. Urine: sediment (mg/dl), protein (g/g), protein/creatinine ratio measured using the laboratory standard of City Clinic Husum, Germany or Dr. Limbach Laboratory Heidelberg, Germany, and the Clinic of Kiel, Germany	—

Measure

Time frame

Measured at Visit 2 (baseline), 3rd and 5th days in the first therapy phase of the study, 1st 3rd and 5th day of the second therapy phase and Visit 4 (3 days post last intervention). 1. O2C measurement under external counterpulsation therapy treatment measured using LEA Medizintechnik Giesen (Units and % oxygen) 2. Changes to perfusion of tissue (blood flow verlocity, blood filling of micro vessels, capillary sinus oxygen saturation) 3. Serum: 3.1. Creatinine (mg/dl) using the enzymatic method 3.2. Urea (mg/dl) using photometry 3.3. LDH (U/I) using photometry 3.4. Myoglobin (µg/l) using Sandwich Immunoassay 3.5. Creatine Kinase (g/g) using the enzymatic method 3.6. Potassium(mmol/l) using ion-selective electrode (ISE) 3.7. Lactate (mmol/l) using photometry 4. Urine: sediment (mg/dl), protein (g/g), protein/creatinine ratio measured using the laboratory standard of City Clinic Husum, Germany or Dr. Limbach Laboratory Heidelberg, Germany, and the Clinic of Kiel, Germany

—

Countries

Germany

Contacts

Public ContactPhilipp Hillmeister

p.hillmeister@klinikum-brandenburg.de+49 3381411556

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026