Apply the single use NeurOS cerebral oximetry sensor adhesive onto patients' head who are going to have CEA surgery in the operating room before anesthesia induction.

Carotid Disease

NeurOS system pads will be placed on patients' head for monitoring.

NeurOS

Jewish Hospital

Study of Regional Cerebral Oxygenation and Brain Blood Volume Changes During Carotid Endarterectomy Using the NeurOS System

Regional Cerebral Oxygenation during Carotid Endarterectomy

NeurOS Brain Blood Volume during Carotid Endarterectomy

Jiapeng Huang

Principal Investigator

University of Louisville

Patients will have NeurOS pads placed on their foreheads. Continuous monitoring of arterial blood pressure, cerebral oxygenation and brain blood volume index for the whole length of surgery will be recorded and saved in a USB drive for retrieval and analysis. Key point data include: Baseline, Anesthesia Induction, Incision, Carotid Clamping, Clamp Release and Skin Closure. These key points data will be extracted for analysis.

Ischemic Stroke

MCA Infarction

No intervention is planned, this will be a purely retrospective trial.

University of Minnesota

Osmotic Agent Use in Middle Cerebral Artery Stroke

Osmotic Agents Will Improve the Midline Shift in Middle Cerebral Artery Stroke Larger Than 70 cc by 1 mm

Change of midline shift in millimeters at foramen of Monroe level, at six hours or after osmotherapy in the Acute MCA syndrome of greater than 70cc in volume

The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.

endarterectomy with sonolysis (continual transcranial Doppler monitoring)

carotid stenting with sonolysis (continual transcranial Doppler monitoring)

endarterectomy with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
endarterectomy: carotid endarterectomy

CEA With Sonolysis

endarterectomy without sonolysis
endarterectomy: carotid endarterectomy

CEA Without Sonolysis

carotid stenting with sonolysis (continual transcranial Doppler monitoring)
sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
carotid stenting: percutaneous transluminal angioplasty and stenting

Carotid Stenting With Sonolysis

carotid stenting without sonolysis
carotid stenting: percutaneous transluminal angioplasty and stenting

Carotid Stenting Without Sonolysis

Total

Sex: Female, Male

Region of Enrollment

The number of participants with a new brain infarctions in sonolysis group detected using magnetic resonance examination 24 hours after carotid endarterectomy or carotid stenting.
Substudy: The number of participants with a new brain infarctions on brain diffusion-weighted magnetic resonance imaging performed 24 hours after intervention in carotid endarterectomy and carotid stenting groups.

Carotid Endarterectomy With Sonolysis

Carotid Endarterectomy Without Sonolysis

Participants With a New Brain Infarction Detected Using Magnetic Resonance

The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.
Substudy: The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups.

Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups

The changes in cognitive functions after carotid endarterectomy and carotid stenting measured by Mini-Mental State Examination using periprocedural sonolysis.
Substudy: The changes in cognitive functions after intervention measured by Mini-Mental State Examination between carotid endarterectomy and carotid stenting groups.
Range of scores possible for the Mini-Mental State Examination: 0 - 30 points. Higher values in this range are considered to be a better outcome.

Cognitive Decline

The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system during carotid endarterectomy and carotid stenting using periprocedural sonolysis.
Substudy: The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system between carotid endarterectomy and carotid stenting groups.

Number of Participants With Clinical Manifested Brain Infarction

The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.
Substudy: The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups.

Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups

The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) after carotid endarterectomy and carotid stenting using periprocedural sonolysis.
Substudy: The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) between carotid endarterectomy and carotid stenting groups.

Number of Participants With Clinical Vascular Event or Death

Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.

Number of Participants With Complications

Overall Study

Prof. David Skoloudik, MD, Ph.D.

Internal Carotid Artery Stenosis

continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes

sonolysis

endarterectomy

percutaneous transluminal angioplasty and stenting

carotid stenting

University Hospital Ostrava

SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy

Risk Reduction of Symptomatic and Silent Brain Infarctions During Carotid Endarterectomy and Carotid Stenting Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring

carotid stenosis/edema

Study of Regional Cerebral Oxygenation and Brain Blood Volume Changes During Carotid Endarterectomy Using the NeurOS System

Osmotic Agent Use in Middle Cerebral Artery Stroke

SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy

Blood Pressure Lowering in Acute Stroke Trial (BLAST)

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