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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list