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 January 2011, ref: EK 24/11
Study design
Open comparative randomized controlled prospective clinical pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact eva_elina.buschmann@charite.de 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.
Details of Joint Secondary Sponsor:
Universitätsklinikum Freiburg
Abteilung für Neurologie
Breisacherstr. 64
79106 Freiburg
Germany
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
Fachaerztin für Innere Medizin
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
Funders
Funder type
Hospital/treatment centre
Funder name
Charité University Medicine Berlin (Charité Universitätsmedizin Berlin) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Medical Center Freiburg, Department of Neurology (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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