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

Not Applicable

Completed

• Conditions: ECP effects on cerebral artery stenoses; Circulatory System

• Registration Number: ISRCTN77215948
• Lead Sponsor: Charité University Medicine Berlin (Charité Universitätsmedizin Berlin) (Germany)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29924461 [added 17/04/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-16
• Study Completion: 2012-11-30
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)