Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study.

Study Overview
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Brief Summary
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Neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. Accumulating clinical and experimental evidence suggests a causal relationship between brain damage and heart dysfunction.

Official Title
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Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study.

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: MOSTCAREup Monitoring
* Device: Ecocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Adult patients aged ≥ 18 years. Acute supratentorial or carotid stroke. Exclusion criteria 1. Invasive arterial signal unsuitable to obtain hemodynamic data. 2. Emergency neurosurgery needed before intra-arterial treatment. 3. Once enrolled, the patient can be excluded from the study because of one of the following intraoperative conditions: Intraoperative technical limitations limiting or impeding the arterial re-opening Persistent low quality of the arterial signal. After positioning the patient and zeroing the arterial signal, the arterial waveform is checked for quality by means of a square-wave test and optimized in the case of the occurrence of under or over-damping.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sovratentorial ischemic stroke<br> | Device: MOSTCAREup Monitoring<br>* The patients will be equipped with mini-invasive hemodynamic monitoring (the MOSTACAREup system). The MOSTCAREup obtains the hemodynamic data from either the same arterial femoral line used by the neuro-radiologist to perform the treatment or from a dedicated radial artery, as decided by the attending anesthetist to monitor and optimize arterial pressure (the decision to use the arterial line is at discretion of the attending anesthetist for clinical reasons and does not delay the procedure, which starts using always the femoral access).<br>Device: Ecocardiography<br>* Echocardiography will be performed 1) soon after the end of the treatment (whenever possible, avoiding delays, before od during the treatment in the angiography room); 2) at day 1 after the procedure; 3) at day 3 after the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output measurement | Changes of cardiac output of the enrolled patients before and after clot removal. | Up to 6 hours after clot removal | 
| Arterial elastance measurement | Changes of arterial elastance of the enrolled patients before and after clot removal. | Up to 6 hours after clot removal | 
| Arterial blood pressure measurement | Changes of arterial blood pressure of the enrolled patients before and after clot removal. | Up to 6 hours after clot removal | 
| Heart rate variability measurement | Changes of heart rate variability of the enrolled patients before and after clot removal. | Up to 6 hours after clot removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transthoracic echocardiography | Ejection Fraction measurement | at the admission | 
| Transthoracic Echocardiography | wave E assessment | up to 3 weeks after clot removal | 
| Transthoracic Echocardiography | wave A assessment | up to 3 weeks after clot removal | 
| Transthoracic Echocardiography | wave e' assessment | up to 3 weeks after clot removal |