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SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial.
Trials 2017; 18(1):25T

Abstract

BACKGROUND

Carotid endarterectomy (CEA) is a beneficial procedure for selected patients with an internal carotid artery (ICA) stenosis. Surgical risk of CEA varies from 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 maximal diagnostic energy on the reduction of the incidence of stroke, transient ischemic attack (TIA) and brain infarction detected using magnetic resonance imaging (MRI) by the activation of the endogenous fibrinolytic system during CEA.

METHODS/DESIGN

Design: a multicenter, randomized, double-blind, sham-controlled trial.

SCOPE

international, multicenter trial for patients with at least 70% symptomatic or asymptomatic ICA stenosis undergoing CEA.

INCLUSION CRITERIA

patients with symptomatic or asymptomatic ICA stenosis of at least 70% are candidates for CEA; a sufficient temporal bone window for TCD; aged 40-85 years, functionally independent; provision of signed informed consent. Randomization: consecutive patients will be assigned to the sonolysis or control (sham procedure) group by computer-generated 1:1 randomization. Prestudy calculations showed that a minimum of 704 patients in each group is needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 10% would be lost to follow-up or refuse to participate in the study (estimated 39 endpoints).

ENDPOINTS

the primary endpoint is the incidence of stroke or TIA during 30 days after CEA and the incidence of new ischemic lesions on brain MRI performed 24 h after CEA in the sonolysis and control groups. Secondary endpoints are occurrence of death, any stroke, or myocardial infarction within 30 days, changes in cognitive functions 1 year post procedure related to pretreatment scores, and number of new lesions and occurrence of new lesions ≥0.5 mL on post-procedural brain MRI.

ANALYSIS

descriptive statistics and linear/logistic multiple regression models will be performed. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat.

DISCUSSION

Reduction of the periprocedural complications of CEA using sonolysis as a widely available and cheap method may significantly increase the safety of CEA and extend the indication criteria for CEA.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02398734 . Registered on 20 March 2015.

Authors+Show Affiliations

Department of Neurosurgery, Comprehensive Stroke Center, University Hospital Ostrava, Ostrava, Czech Republic.Department of Neurosurgery and Neurooncology, Comprehensive Stroke Center, Military University Hospital, Prague, Czech Republic.Department of Neurosurgery and Neurooncology, Comprehensive Stroke Center, Military University Hospital, Prague, Czech Republic.Department of Neurology, Jessenius Faculty of Medicine in Martin, Comenius University, Bratislava, Slovak Republic.Department of Neurology, Comprehensive Stroke Center, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic.Department of Neurology, Comprehensive Stroke Center, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic.Department of Neurosurgery, Comprehensive Stroke Center, University Hospital Ostrava, Ostrava, Czech Republic. Center for Research and Science, Faculty of Health Sciences, Palacký University Olomouc, Olomouc, Czech Republic.Department of Neurosurgery, Comprehensive Stroke Center, Liberec Hospital, Liberec, Czech Republic.Department of Neurosurgery, Comprehensive Stroke Center, České Budějovice Hospital, České Budějovice, Czech Republic. Department of Neurosurgery, Comprehensive Stroke Center, University Hospital Plzeň, Plzeň, Czech Republic.Department of Neurosurgery, Comprehensive Stroke Center, University Hospital Plzeň, Plzeň, Czech Republic.Department of Neurology, Faculty Hospital Nitra, Constantine Philosopher University Nitra, Nitra, Slovakia.Center for Research and Science, Faculty of Health Sciences, Palacký University Olomouc, Olomouc, Czech Republic. Department of Biophysics, Faculty of Medicine and Dentistry, Institute of Molecular and Translational Medicine, Palacký University, Olomouc, Czech Republic.Department of Neurosurgery and Neurooncology, Comprehensive Stroke Center, Military University Hospital, Prague, Czech Republic. Department of Neurology, Comprehensive Stroke Center, Charles University Faculty of Medicine and University Hospital Hradec Králové, Hradec Králové, Czech Republic.Center for Research and Science, Faculty of Health Sciences, Palacký University Olomouc, Olomouc, Czech Republic. skoloudik@hotmail.com. Department of Neurology, Comprehensive Stroke Center, University Hospital Ostrava, Ostrava, Czech Republic. skoloudik@hotmail.com.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28095924

Citation

Hrbáč, Tomáš, et al. "SONOlysis in Prevention of Brain InfaRctions During Internal Carotid Endarterectomy (SONOBIRDIE) Trial - Study Protocol for a Randomized Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 25.
Hrbáč T, Netuka D, Beneš V, et al. SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial. Trials. 2017;18(1):25.
Hrbáč, T., Netuka, D., Beneš, V., Nosáľ, V., Kešnerová, P., Tomek, A., ... Školoudík, D. (2017). SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial. Trials, 18(1), p. 25. doi:10.1186/s13063-016-1754-x.
Hrbáč T, et al. SONOlysis in Prevention of Brain InfaRctions During Internal Carotid Endarterectomy (SONOBIRDIE) Trial - Study Protocol for a Randomized Controlled Trial. Trials. 2017 01 17;18(1):25. PubMed PMID: 28095924.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial. AU - Hrbáč,Tomáš, AU - Netuka,David, AU - Beneš,Vladimír, AU - Nosáľ,Vladimír, AU - Kešnerová,Petra, AU - Tomek,Aleš, AU - Fadrná,Táňa, AU - Beneš,Vladimír,Jr AU - Fiedler,Jiří, AU - Přibáň,Vladimír, AU - Brozman,Miroslav, AU - Langová,Kateřina, AU - Herzig,Roman, AU - Školoudík,David, Y1 - 2017/01/17/ PY - 2016/05/08/received PY - 2016/12/12/accepted PY - 2017/1/19/entrez PY - 2017/1/18/pubmed PY - 2018/3/6/medline KW - Brain infarction KW - Carotid KW - Endarterectomy KW - Sonolysis KW - Stroke SP - 25 EP - 25 JF - Trials JO - Trials VL - 18 IS - 1 N2 - BACKGROUND: Carotid endarterectomy (CEA) is a beneficial procedure for selected patients with an internal carotid artery (ICA) stenosis. Surgical risk of CEA varies from 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 maximal diagnostic energy on the reduction of the incidence of stroke, transient ischemic attack (TIA) and brain infarction detected using magnetic resonance imaging (MRI) by the activation of the endogenous fibrinolytic system during CEA. METHODS/DESIGN: Design: a multicenter, randomized, double-blind, sham-controlled trial. SCOPE: international, multicenter trial for patients with at least 70% symptomatic or asymptomatic ICA stenosis undergoing CEA. INCLUSION CRITERIA: patients with symptomatic or asymptomatic ICA stenosis of at least 70% are candidates for CEA; a sufficient temporal bone window for TCD; aged 40-85 years, functionally independent; provision of signed informed consent. Randomization: consecutive patients will be assigned to the sonolysis or control (sham procedure) group by computer-generated 1:1 randomization. Prestudy calculations showed that a minimum of 704 patients in each group is needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 10% would be lost to follow-up or refuse to participate in the study (estimated 39 endpoints). ENDPOINTS: the primary endpoint is the incidence of stroke or TIA during 30 days after CEA and the incidence of new ischemic lesions on brain MRI performed 24 h after CEA in the sonolysis and control groups. Secondary endpoints are occurrence of death, any stroke, or myocardial infarction within 30 days, changes in cognitive functions 1 year post procedure related to pretreatment scores, and number of new lesions and occurrence of new lesions ≥0.5 mL on post-procedural brain MRI. ANALYSIS: descriptive statistics and linear/logistic multiple regression models will be performed. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. DISCUSSION: Reduction of the periprocedural complications of CEA using sonolysis as a widely available and cheap method may significantly increase the safety of CEA and extend the indication criteria for CEA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02398734 . Registered on 20 March 2015. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/28095924/SONOlysis_in_prevention_of_Brain_InfaRctions_During_Internal_carotid_Endarterectomy__SONOBIRDIE__trial___study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1754-x DB - PRIME DP - Unbound Medicine ER -