Tolerability of enhanced external counter pulsation to improve circulation in patients with vascular disease
| ISRCTN | ISRCTN15405726 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15405726 |
| Secondary identifying numbers | Version 1.5 06/08/2019 |
- Submission date
- 13/11/2019
- Registration date
- 09/12/2019
- Last edited
- 09/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
Coronary heart disease is the term that describes what happens when the heart's blood supply is blocked or interrupted by a build-up of fatty substances in the coronary arteries. Numerous clinical studies have shown that external counterpulsation (EPT) relieves symptoms of coronary heart disease (angina pectoris and dyspnea) and reduces the incidence of cardiovascular events.
Who can participate?
Patients aged 18 years or older suffering from systemic atherosclerosis
What does the study involve?
In the lying position, three pairs of pneumatic cuffs are wrapped around the patient’s hip, thighs and lower leg with different pressure settings. Patients are treated with high-pressure counterpulsation for one hour a day for five days, and with low-pressure counterpulsation for one hour a day for five days
What are the possible benefits and risks of participating?
Patients benefit from the study therapy in particular by improvement of endothelial function and vascular regeneration. Possible risks are provided by cuff pressure on tissue (tissue damage) or discomfort
Where is the study run from?
Brandenburg Medical School (MHB)
When is the study starting and how long is it expected to run for?
October 2019 to March 2020
Who is funding the study?
Brandenburg Medical School (MHB)
Who is the main contact?
Dr Philipp Hillmeister
p.hillmeister@klinikum-brandenburg.de
Contact information
Dr Philipp Hillmeister
Public
Public
Brandenburg Medical School
Clinic Brandenburg
Department for Angiology
Brandenburg an der Havel
14770
Germany
| Phone | +49 3381411556 |
|---|---|
| p.hillmeister@klinikum-brandenburg.de |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | EPT-Comfort |
| Study hypothesis | The aim of the study is to test how tolerable external pulsation therapy (EPT) is for patients with systemic atherosclerosis (CHD and manifest PAOD), and whether as a result of EPT any measurable change occurs to the microcirculation, as well as whether this effect is dependent on the pressure level. In addition, the aim is to test whether the conventional treatment (see above) with high-pressure EPT is comparable with low-pressure L-EPT treatment. A further aim is to clarify whether any possible influence occurs only for a short term or for a long term, and whether it activates the regeneration capacity of the vessels by increasing the shear stress in the leg arteries, and stimulates peripheral arteriogenesis to compensate for the PAOD. |
| Ethics approval(s) | Approved 23/09/2019, Ethics Committee Schleswig-Holstein, Germany - Ethikkommission bei der Ärztekammer Schleswig-Holstein, Deutschland (Ethikkommission II, Bismarkstraße 8-12, 23795 Bad Segeberg, Germany; +49 4551 803432; anne.hostmann@aeksh.de), ref: 063/19 II |
| Condition | 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. |
| Intervention | 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 atheroslerosis, coronary heart diseases and peripheral artery disease (Stadium II). In a randomized cross over trial patients are treated with high pressure counterpulsation for one hour a day for five days, and with low pressure counterpulsation each day for five days. Quality of life, microcirculation, hemolysis, myolysis, and kidney function parameters are analysed in the following. Both methods (high and low pressure pulsation therapy) are tested for compatibility, safety, and qualitiy of life. Medicinal product (Renew, NCP-5): External leg cuffs with ECG-controlled variable compressed air compression equipment (principle of external pulsation therapy). Two therapeutic sequences (phases): 1. Low-pressure external pulsation therapy (EPT) with limited therapeutic pressure (corresponding to average arterial pressure) for 60 min on 5 successive days. n = 20 2. High-pressure EPT (EECP = enhanced EPT) with conventional therapeutic pressure (250–280 mmHg) for 60 min on 5 successive days. n = 20 Progression: 1. Visit 1 - Recruitment 2. Visit 2 - Baseline Analysis 3. Randomization (using an online randomization tool) 4. Start either high-pressure EECP or low-pressure EPT. Therapy 1. Total duration therapy: 5 days (one week) for 1h each day 5. 7 days break 6. Visit 3: Laboratory and Questionaire 7. Therapy 2: Start either low-pressure EPT or high-pressure EECP (cross-over design. Start with the other possible therapy): total duration therapy: 5 days (one week) for 1h each day 8. 3 days break 9. Visit 4: Laboratory and Questionaire 10. End of study |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Renew, NCP-5 |
| Primary outcome measure | Quality of Life measured using German IGZ Quality of Life Standard Questionnaire at baseline (visit 2), visit 3, and visit 4 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2019 |
| Overall study end date | 31/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/10/2019 |
| Recruitment end date | 01/01/2020 |
Locations
Countries of recruitment
- Germany
Study participating centre
Interdisziplinäres Gefäßzentrum Nord (Interdisciplinary Vascular Center)
Erichsenweg 16
Husum
25813
Germany
Husum
25813
Germany
Sponsor information
Interdisziplinäre Gefäßzentrum Nord
Hospital/treatment centre
Hospital/treatment centre
Erichsenweg 16
Husum
25813
Germany
| Phone | +49 4841 6601520 |
|---|---|
| christian.klaproth@klinikum-nf.de | |
| Website | http://www.praxis-fuer-gefaessmedizin.de/ |
"ROR" |
https://ror.org/02rppq041 |
Funders
Funder type
Government
Brandenburg Medical School (MHB)
No information available
Results and Publications
| Intention to publish date | 01/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publication in a peer-reviewed Journal such as VASA or Acta Physiologica. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
09/12/2019: Internal review.
21/11/2019: Trial’s existence confirmed by Ethics Committee Schleswig-Holstein, Germany
