Condition category
Circulatory System
Date applied
26/06/2012
Date assigned
16/07/2012
Last edited
29/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 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

http://www.charite.de

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

Publication citations

Additional files

Editorial Notes