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.

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.

Internal Carotid Artery Stenosis

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.

sonolysis

University Hospital Ostrava

SONOlysis in Prevention of Brain InfaRctions During Internal Carotid Endarterectomy

Risk Reduction of Symptomatic and Silent Brain Infarctions During Carotid Endarterectomy by the Ultrasound Activation of Endogenous Fibrinolytic System Using Sonolysis (Transcranial Doppler Monitoring)

The incidence of ischemic stroke, transient ischemic attack and death within 30 days in sonolysis and control groups

The incidence of death within 30 days, collected from the family members and/or from electronic hospital database and/or health insurance companies databases

The incidence of death within 1 year, collected from the family members and/or from electronic hospital database and/or health insurance companies databases

The incidence of any stroke within 30 days, including 1/ cerebral ischemic stroke defined as acute focal neurological dysfunction caused by focal infarction at single or multiple sites of the brain or retina with evidence coming either from symptoms duration lasting more than 24 h and neuroimaging or other technique in the clinically relevant area or the brain; 2/ intracerebral hemorrhage defined as acute neurological dysfunction caused by hemorrhage within the brain parenchyma or in the ventricular system; 3/ subarachnoid hemorrhage defined as acute neurological dysfunction caused by subarachnoid hemorrhage; 4/ stroke not known if ischemic or hemorrhagic defined as acute focal neurological dysfunction lasting more than 24 hours (or lead to death in less than 24 hours), but subtype of stroke (ischemic or hemorrhagic) has not been determined by neuroimaging or other techniques.

The incidence of myocardial infarction within 30 days, 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

Changes in cognitive functions measured by Addenbrooke's Cognitive Examination Revised (ACE-R) at 1 year (at visit 5) compared to baseline (at visit 2)

Changes in cognitive function measured by Addenbrooke's Cognitive Examination Revised (ACE-R) 30 days after randomization (at visit 4) compared to baseline (at visit 2)

Changes in cognitive function measured by Addenbrooke's Cognitive Examination Revised (ACE-R) 24 hours after CEA (at visit 3) compared to baseline (at visit 2)

Appearance of at least one new ischemic lesion on post-procedural brain MR (24 hours after CEA, visit 3), defined as hyperintense region on post-intervention DWI that was not present on pre-treatment images (visit 1).

Number of new ischemic lesions on post-procedural brain MR (24 hours after CEA, visit 3), defined as hyperintense regions on post-intervention DWI that were not present on pre-treatment images (visit 1).

Appearance of at least one new ischemic lesion ≥0.5 mL on post-procedural brain DWI-MR (24 hours after CEA, visit 3), defined as hyperintense regions on post-intervention DWI that were not present on pre-treatment images (visit 1) with total infarct volume ≥0.5 mL. The volume of new brain infarctions will be measured manually. Infarct volumes will be calculated as the total hyperintense area in single slices multiplied by an effective slice thickness [(actual slice thickness + distance factor)/interslice gap].

Appearance of at least one new ipsilateral ischemic lesions on post-procedural brain DWI-MR (24 hours after CEA, visit 3), defined as hyperintense regions on post-intervention DWI in the territory of intervened internal carotid artery that were not present on pre-treatment images (visit 1).

Incidence of hemorrhagic stroke including subarachnoid hemorrhage within 30 days

Incidence of intracranial bleeding (including brain microbleeds) on control T2*-MR in the MR substudy

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

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

The total score in the Patient and Observer Scar Assessment Scale in patients after carotid endarterectomy using short longitudinal and transverse skin incision (Substudy)

Changes in cognitive functions measured by MMSE at 1 year (at visit 5) compared to baseline (at visit 2)

Changes in cognitive functions measured by MMSE at 30 days after randomization (at visit 4) compared to baseline (at visit 2)

Changes in cognitive functions measured by MMSE at 24 hours after CEA (at visit 3) compared to baseline (at visit 2)

Changes in cognitive functions measured by Clock Drawing Test at 1 year (at visit 5) compared to baseline (at visit 2)

Changes in cognitive functions measured by Clock Drawing Test at 30 days after randomization (at visit 4) compared to baseline (at visit 2)

Changes in cognitive functions measured by Clock Drawing Test at 24 hours after CEA (at visit 3) compared to baseline (at visit 2)

Changes in cognitive functions measured by Speech Fluency Test at 1 year (at visit 5) compared to baseline (at visit 2)

Changes in cognitive functions measured by Speech Fluency Test at 30 days after randomization (at visit 4) compared to baseline (at visit 2)

Changes in cognitive functions measured by Speech Fluency Test at 24 hours after CEA (at visit 3) compared to baseline (at visit 2)

The IPD sharing plan will be created prior to publication of study results.

Ústřední fakultní vojenská nemocnice, Praha, Czechia

Vítkovická nemocnice, Ostrava, Czechia

Masarykova nemocnice v Ústí nad Labem, Ústí nad Labem, Czechia

Nemocnice České Budějovice, České Budějovice, Czechia

Fakultní nemocnice Hradec Králové, Hradec Králové, Czechia

Fakultní nemocnice Plzeň, Plzeň, Czechia

Krajská nemocnice Liberec, Liberec, Czechia

Fakultná nemocnica Martin, Martin, Slovakia

Nemocnice Jihlava, Jihlava, Czechia

Nemocnice na Homolce, Praha, Czechia

Fakultní nemocnice Motol, Praha, Czechia

Fakultná nemocnica Nitra, Nitra, Slovakia

Fakultní nemocnice Olomouc, Olomouc, Czechia

Fakultná nemocnica Košice, Košice, Slovakia

Krajská nemocnice T. Bati, Zlín, Czechia

Allgemeine Krankenhausl Linz, Linz, Austria

Patients with symptoms of deep venous thrombosis less than for 2 weeks, with thrombus occluding without any reperfusion in color mode in the common femoral vein (CFV), the femoral vein (FV) or the popliteal vein (PV)

tics/infarction

SONOlysis in Prevention of Brain InfaRctions During Internal Carotid Endarterectomy

Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging

Најкомплетната база на податоци за лековити билки поддржана од науката