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Trial record 31 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

SONOlysis in Prevention of Brain InfaRctions During Internal Carotid Endarterectomy (SONOBIRDIE)

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ClinicalTrials.gov Identifier: NCT02398734
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Military University Hospital, Prague
Vitkovice Hospital, Ostrava
Masaryk Hospital Usti nad Labem
České Budějovice Hospital
University Hospital Hradec Kralove
University Hospital Pilsen
County Hospital Liberec, Liberec
University Hospital, Martin
Jihlava Hospital, Jihlava
Na Homolce Hospital
University Hospital, Motol
Faculty Hospital Nitra
University Hospital Olomouc
University Hospital Kosice
Tomas Bata Hospital, Czech Republic
Information provided by (Responsible Party):
University Hospital Ostrava

Brief Summary:

SONOBIRDIE Trial is a randomized, single-blind, sham-controlled study designed for a demonstration of the safety and effectiveness of sonolysis (continual transcranial Doppler monitoring) in reduction of risk of stroke or transient ischemic attack (TIA), brain infarctions and cognitive decline using a 2-MHz diagnostic probe with a maximal diagnostic energy on the reduction of risk of brain infarctions by the activation of endogenous fibrinolytic system during carotid endarterectomy (CEA) in patients with ≥ 70% symptomatic or asymptomatic internal carotid artery stenosis.

The sample size is based on an expected 2.5% reduction of stroke or TIA during the 30-day postoperative period in the sonolysis group (estimated prevalence, 1.5 %) compared to the control group (estimated prevalence, 4 %). Pre-study 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.

Consecutive patients will be assigned to the sonolysis or control group by a computer-generated 1:1 randomization. In patients randomized into sonolysis group, middle cerebral artery segment in a depth of 55 mm will be continuously monitored during intervention using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic energy.

In patients randomized into control group, the transcranial Doppler probe will be fixed in a required position using a special helmet as in sonolysis group patients, but middle cerebral artery segment in a depth of 55 mm will be only localized using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic energy and the TCD monitoring will be stopped afterwards.

Confirmation of the investigators hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CEA with consecutive reduction of stroke or TIA, and the number and volume of brain infarcts, can lead to the increase of the safety of CEA in patients with internal carotid artery stenosis. The investigators can presume that up to 50% of patients indicated for CEA can be treated using these methods in the future.


Condition or disease Intervention/treatment Phase
Internal Carotid Artery Stenosis Device: sonolysis Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Risk Reduction of Symptomatic and Silent Brain Infarctions During Carotid Endarterectomy by the Ultrasound Activation of Endogenous Fibrinolytic System Using Sonolysis (Transcranial Doppler Monitoring)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Sonolysis
In patients randomized into sonolysis group, middle cerebral artery segment in a depth of 55 mm will be continuously monitored during intervention using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic energy. The probe will be fixed in a required position using a special helmet and sonolysis will start before the carotid intervention and will be stopped after the intervention, but at latest after 120 minutes. Transcranial Doppler machine with a 2-MHz diagnostic transcranial Doppler probe will be used. This non-diagnostic transcranial Doppler monitoring will be performed without detection of microembolic signals or detection of changes in blood flow. Device sound and Doppler wave imaging will be switched off. Only sonographer will be unblinded to the procedure.
Device: sonolysis
Continual transcranial Doppler monitoring of ipsilateral middle cerebral artery using a transcranial Doppler systems (e.g. DWL Multi-Dop T1, DWL, Sipplingen, Germany) with a diagnostic 2-MHz probe.
Other Name: sonothrombolysis

Sham Comparator: Shame sonolysis
In patients randomized into control group, the transcranial Doppler probe will be fixed in a required position using a special helmet as in sonolysis group patients, but middle cerebral artery segment in a depth of 55 mm will be only localized using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic energy and the transcranial Doppler monitoring will be stopped afterwards. Patients in the control group will undergo a sham procedure in which further sonolysis (transcranial Doppler monitoring) will not be conducted.
Device: sonolysis
Continual transcranial Doppler monitoring of ipsilateral middle cerebral artery using a transcranial Doppler systems (e.g. DWL Multi-Dop T1, DWL, Sipplingen, Germany) with a diagnostic 2-MHz probe.
Other Name: sonothrombolysis




Primary Outcome Measures :
  1. Occurence of stroke or transient ischemic attack [ Time Frame: 30 days after intervention ]
    The incidence of stroke or transient ischemic attack during 30 days after the carotid endarterectomy in sonolysis and control groups


Secondary Outcome Measures :
  1. Occurrence of death, any stroke, or myocardial infarction [ Time Frame: 30 days after intervention ]
    Occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction is defined as post-interventional cardiac troponin T level increase > 2 times the normal upper limit in addition to either chest pain, symptoms consistent with heart ischemia, or electrocardiographic evidence of ischemia)

  2. Cognitive decline [ Time Frame: 1 year after intervention ]
    Changes in cognitive functions as evidenced by Addenbrooke's Cognitive Examination Revised, Mini Mental State Examination, Clock Drawing Test, or Verbal Fluency Test scores 1 year post-procedure relative to pre-treatment scores

  3. Occurence of new ischemic lesions ≥ 0.5 mL on brain DWI-MRI (Substudy) [ Time Frame: 24 hours after intervention ]
    Number of new lesions and occurrence of new lesions ≥ 0.5 mL on post-procedural brain DWI-MRI

  4. Occurence of ipsilateral new ischemic lesions on brain DWI-MRI (Substudy) [ Time Frame: 24 hours after intervention ]
    Incidence of ipsilateral new ischemic lesions on post-procedural brain DWI-MRI

  5. Adverse events [ Time Frame: 30 days after intervention ]
    Summary of any adverse events


Other Outcome Measures:
  1. Occurence of new ischemic lesions on brain DWI-MRI (Substudy) [ Time Frame: 24 hours after intervention ]
    The incidence of new ischemic lesions on brain DWI-MRI performed 24 hours after the CEA in sonolysis and control groups - Primary outcome for the Substudy

  2. Occurence of new ischemic lesions on brain DWI-MRI in local anesthesia and general anesthesia (Substudy) [ Time Frame: 24 hours after intervention ]
    The incidence of new ischemic lesions on brain DWI-MRI performed 24 hours after the CEA in patients with surgery in local anesthesia and general anesthesia

  3. Cosmetic outcome in patients after carotid endarterectomy using short longitudinal and transverse skin incision (Substudy) [ Time Frame: 3 months after intervention ]
    The total score in the Patient and Observer Scar Assessment Scale in patients after carotid endarterectomy using short longitudinal and transverse skin incision (Substudy)



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a symptomatic or asymptomatic ICA stenosis ≥ 70 % (NASCET criteria) as detected by a duplex sonography (see Appendix) and confirmed using the computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA).
  • Subject is indicated for CEA according to the criteria set by the American Heart Association.
  • Subject is aged 40 - 85 years.
  • Subject has a sufficient temporal bone window for TCD with detectable blood flow in the MCA.
  • Subject is functionally independent with a modified Rankin score value of 0 - 2 points.
  • Informed consent is signed by the subject.

Exclusion Criteria:

  • Subject has been participating in another clinical trial within last 6 weeks.
  • Subject has any other medical condition that would make him/her inappropriate for study participation, in the Investigator opinion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398734


Contacts
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Contact: David Skoloudik, MD,PhD,FESO +420597375613 skoloudik@hotmail.com
Contact: Martin Roubec, MD, PhD +420597375630 martin.r@centrum.cz

Locations
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Czechia
University Hospital Ostrava Recruiting
Ostrava, Czech Republic, Czechia, 70852
Contact: David Skoloudik, MD,PhD,FESO    00420597375613    skoloudik@hotmail.com   
Contact: Martin Roubec, MD, PhD    00420597375630    martin.r@centrum.cz   
Principal Investigator: David Skoloudik, MD, PhD         
Sponsors and Collaborators
University Hospital Ostrava
Military University Hospital, Prague
Vitkovice Hospital, Ostrava
Masaryk Hospital Usti nad Labem
České Budějovice Hospital
University Hospital Hradec Kralove
University Hospital Pilsen
County Hospital Liberec, Liberec
University Hospital, Martin
Jihlava Hospital, Jihlava
Na Homolce Hospital
University Hospital, Motol
Faculty Hospital Nitra
University Hospital Olomouc
University Hospital Kosice
Tomas Bata Hospital, Czech Republic
Investigators
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Study Chair: David Skoloudik, MD,PhD,FESO Department of Neurology, University Hospital Ostrava

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02398734     History of Changes
Other Study ID Numbers: CZ20150305
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital Ostrava:
sonolysis
carotid endarterectomy
stroke prevention
brain infarction

Additional relevant MeSH terms:
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Carotid Stenosis
Infarction
Brain Infarction
Ischemia
Pathologic Processes
Necrosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Stroke