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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/27283933:_____/17:00005310 RIV/00216208:11130/17:10360697 RIV/00216208:11140/17:10360697 RIV/00216208:11150/17:10360697 a 7 dalších

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

30103 - Neurosciences (including psychophysiology)

Projekt

<a href="/cs/project/NV16-29148A" target="_blank" >NV16-29148A: Sonolýza v průběhu karotické endarterektomie v prevenci vzniku mozkového infarktu detekovaného pomocí magnetické rezonance - SONOBIRDIE MR Trial</a><br>

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

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

Název periodika

Trials

ISSN

1745-6215

e-ISSN

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Svazek periodika

18

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

1

Strana od-do

25

Kód UT WoS článku

000392029700001

EID výsledku v databázi Scopus

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