Condition category
Circulatory System
Date applied
26/06/2012
Date assigned
16/07/2012
Last edited
13/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to find out whether external counterpulsation (ECP) improves the blood flow of patients with stenotic (narrowed) or occluded (blocked) cerebral arteries (brain-supplying blood vessels).

Who can participate?
Patients aged over 60 with stenosis (narrowing) or occlusion (blockage) of one of the internal carotid arteries (the major blood vessels in the neck that supply blood to the brain, neck, and face)

What does the study involve?
Participants are randomly allocated to undergo either ECP treatment followed by sham ECP treatment, or undergo the same procedures in the reverse sequence. To undergo ECP, the patient lies down, has pneumatic (inflatable) cuffs wrapped around their calves and lower and upper thighs, and is connected to a heart monitor. The cuffs inflate at the beginning of the filling phase of the heart and deflate at the beginning of the contraction. Sham ECP is done with inflation pressures that are lower than the pressure required for a beneficial effect. One ECP cycle lasts 20 minutes. During ECP, assessments are carried out continuously including: ultrasound examination of the median carotid artery, blood pressure measurement, and electrocardiogram (ECG) recording the electrical activity of the heart. Assessments are also carried out before ECP, in between treatment cycles, after ECP and at 1-month follow-up.

What are the possible benefits and risks of participating?
The assessments may aid in the diagnosis of blood vessel disease and may lead to changes in treatment. ECP may provide a non-invasive way to increase the blood flow of patients with stenosis of the carotid/cerebral arteries. ECP has been shown to be safe in patients with blood vessel disease. Side effects may include superficial skin abrasions, redness and muscular pain during the first cycle. Therefore, participants are offered protective pants to wear underneath the cuffs. The Berlin ECP centre has used these on patients with long-term ECP sessions and successfully avoided side effects.

Where is the study run from?
1. Charité Universitätsmedizin Berlin (Germany)
2. Albert-Ludwigs-Universität Freiburg (Germany)

When is the study starting and how long is it expected to run for?
July 2012 to November 2012

Who is funding the study?
1. Charité Universitätsmedizin Berlin (Germany)
2. Albert-Ludwigs-Universität Freiburg(Germany)

Who is the main contact?
Dr Eva-Elina Buschmann

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eva Elina Buschmann

ORCID ID

Contact details

Fachaerztin für Innere Medizin
Charité Universitätsmedizin Berlin
CVK
Augustenburger Platz 1
Berlin
D-13353
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Art.Net Brain I Trial: A prospective, randomised, controlled trial to assess the effect of external counterpulsation on cerebral hemodynamics in patients with hemodynamically relevant stenosis or occlusion of the cerebral arteries

Acronym

Study hypothesis

It is hypothesised that external counterpulsation (ECP) treatment improves cerebral blood flow velocity in patients with stenotic or occluded cerebral arteries.

The null hypothesis is that there will be no difference in blood flow velocity following ECP or Sham treatment.

Ethics approval

Albert-Ludwigs-Universitaet Freiburg, University Medical Center Freiburg, Ethics Committee, 27/01/2011, ref: EK 24/11

Study design

Open comparative randomized controlled prospective clinical pilot study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

ECP effects on cerebral artery stenoses

Intervention

The study will involve 24 patients >60 years of age with a unilateral >80% stenosis (local stenosis grade) or occlusion of the internal carotid artery, who are willing to be assigned to any of the study intervention schemes, recruited at the University Medical Center Freiburg, Department of Neurology, Freiburg, Germany. Participation will be over a one-month period (until last follow-up). Participants will be assigned to one cycle of ECP-active followed by one cycle of ECP-sham or vice versa.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mean cerebral blood flow velocity (CBFVmean) in the A. cerebri media ipsilateral and contralateral to the stenosis of the internal carotid artery before, during and after ECP therapy (ECP active and ECP sham)

Secondary outcome measures

1. CO2 reactivity (CO2normo, CO2hyper) before and after ECP active and ECP sham
2. CO2RHb, CO2RHbOx, CO2RHbRed before and after ECP active and ECP sham
3. Trans cranial Doppler envelope curve analysis (Vsystolisch max, Vdiastol. max, systolic and diastolic acceleration, PI and RI) before, during and after ECP active and ECP sham
4. Parameters of dynamic cerebral autoregulation (phase shift; spontaneous fluctuation) before, during and after ECP active and ECP sham
5. Cerebrovascular resistance before, during and after ECP active and ECP sham
6. Baro receptor reflex sensitivity before, during and after ECP active and ECP sham
7. Near infrared spectroscopy (TOI, THI, HbTot, HbOx, HbRed) before, during and after ECP active and ECP sham
8. Fow-volume analysis of the distal extracranial segment of the internal carotid artery before, during and after ECP active and ECP sham

Overall trial start date

01/07/2012

Overall trial end date

30/11/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >60 years
2. Unilateral >80% stenosis (local stenosis grade) or occlusion of the internal carotid artery
3. Willing to be assigned to any of the study intervention schemes

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Contralateral stenosis of the carotid artery >70%
2. No transtemporal acoustic window for transcranial Doppler sonography, cerebral ischemic event <3 moths prior
3. Atrial fibrillation or flutter
4. Severe arterial hypertension (>180 mmHg systolic, >100 mmHg diastolic)
5. Cardiac ejection fraction <35%
6. Aortic valve insufficiency >II°
7. Tricuspid valve insufficiency >III°
8. Aortofemoral or femoropopliteal bypass
9. Recent thrombosis of lower extremity
10. Hemorrhagic diathesis or clinical signs thereof
11. Dementia or severe cognitive disorder/mental retardation
12. Participation in another clinical trial

Recruitment start date

01/07/2012

Recruitment end date

30/11/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Charité Universitätsmedizin Berlin
Berlin
D-13353
Germany

Sponsor information

Organisation

Charité University Medicine Berlin (Charité Universitätsmedizin Berlin) (Germany)

Sponsor details

Augustenburger Platz 1
Berlin
D-13353
Germany

Sponsor type

University/education

Website

http://www.charite.de

Organisation

Universitätsklinikum Freiburg

Sponsor details

Abteilung für Neurologie
Breisacherstr. 64
Freiburg
79106
Germany

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Charité Universitätsmedizin Berlin

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Germany

Funder name

Albert-Ludwigs-Universität Freiburg

Alternative name(s)

University of Freiburg, Uni Freiburg

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/06/2017: Plain English summary added.