SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F17%3A73580912" target="_blank" >RIV/61989592:15110/17:73580912 - isvavai.cz</a>

Alternative codes found

RIV/27283933:_____/17:00005310 RIV/00216208:11130/17:10360697 RIV/00216208:11140/17:10360697 RIV/00216208:11150/17:10360697 and 7 more

Result on the web

<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240392/" target="_blank" >https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240392/</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s13063-016-1754-x" target="_blank" >10.1186/s13063-016-1754-x</a>

Result language

angličtina

Original language name

SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial

Original language description

Carotid endarterectomy (CEA) is a beneficial procedure for selected patients with an internal carotid artery (ICA) stenosis. Surgical risk of CEA varies between 2 and 15%. The aim of the study is to demonstrate the safety and effectiveness of sonolysis (continual transcranial Doppler monitoring, TCD) using a 2-MHz diagnostic probe with a maximal diagnostic energy on the reduction of stroke, transient ischemic attack (TIA) and brain infarction detected using magnetic resonance imaging (MRI) by the activation of endogenous fibrinolytic system during CEA. Methods/design: Design: a randomized, double-blind, sham-controlled trial. Scope: international, multi-center trial for patients with ≥70% symptomatic or asymptomatic ICA stenosis undergoing CEA. Inclusion criteria: patients with symptomatic or asymptomatic ICA stenosis ≥70% indicated for CEA, a sufficient temporal bone window for TCD, aged 40 - 85 years, functionally independent, signed Informed consent. Randomization: Consecutive patients will be assigned to the sonolysis or control (sham procedure) group by a computer-generated 1:1 randomization. Endpoints: The primary endpoint is the incidence of stroke or TIA during 30 days after the CEA and the incidence of new ischemic lesions on brain MRI performed 24 hours after the CEA in sonolysis and control groups. Secondary end-points are occurrence of death, any stroke, or myocardial infarction within 30 days, changes in cognitive functions 1 year post-procedure related to pre-treatment scores, and number of new lesions and occurrence of new lesions ≥0.5 mL on post-procedural brain MRI.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30103 - Neurosciences (including psychophysiology)

Project

<a href="/en/project/NV16-29148A" target="_blank" >NV16-29148A: SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy – Magnetic Resonance study (SONOBIRDIE MR Trial)</a><br>

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Trials

ISSN

1745-6215

e-ISSN

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Volume of the periodical

18

Issue of the periodical within the volume

1

Country of publishing house

GB - UNITED KINGDOM

Number of pages

1

Pages from-to

25

UT code for WoS article

000392029700001

EID of the result in the Scopus database

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