Art.Net Brain I Trial: To determine whether external counterpulsation positively affects cerebral blood flow in patients with stenotic or occluded cerebral arteries

ISRCTN	ISRCTN77215948
DOI	https://doi.org/10.1186/ISRCTN77215948
Secondary identifying numbers	N/A

Submission date: 26/06/2012
Registration date: 16/07/2012
Last edited: 17/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Eva Elina Buschmann
Scientific

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

Study information

Study design	Open comparative randomized controlled prospective clinical pilot study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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(s)	Albert-Ludwigs-Universitaet Freiburg, University Medical Center Freiburg, Ethics Committee, 27/01/2011, ref: EK 24/11
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2012
Completion date	30/11/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	24
Total final enrolment	28
Key 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
Key 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
Date of first enrolment	01/07/2012
Date of final enrolment	30/11/2012

Locations

Countries of recruitment

Germany

Study participating centre

Charité Universitätsmedizin Berlin

Berlin
D-13353
Germany

Sponsor information

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

Augustenburger Platz 1
Berlin
D-13353
Germany

Website	http://www.charite.de

Universitätsklinikum Freiburg
University/education

Abteilung für Neurologie
Breisacherstr. 64
Freiburg
79106
Germany

Charité
Not defined

Website	http://www.charite.de/en/charite/
"ROR"	https://ror.org/001w7jn25

Funders

Funder type

Hospital/treatment centre

Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)

Alternative name(s): Medical School - Charité - University Medicine Berlin
Location: Germany

Albert-Ludwigs-Universität Freiburg
Private sector organisation / Universities (academic only)

Alternative name(s): Albert Ludwig University of Freiburg, University of Freiburg, Uni Freiburg
Location: Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2018	17/04/2019	Yes	No

Editorial Notes

17/04/2019: Publication reference and total final enrolment added.
13/06/2017: Plain English summary added.