Hemathologic and Imagiologic Predictors of Stroke During Carotid Endarterectomy With Regional Anesthesia

Study Overview
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Brief Summary
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Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

Detailed Description
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The authors hypothesize FGF-23 and GDF-15 could predict cerebral ischemia, postoperative complications and long term major cardiovascular events, particularly in patients developing symptomatic neurologic ischemia after circulation shutdown. Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards. Clarify the pathophysiology of carotid endarterectomy-related stroke and the role of GDF-15, FGF-23, BNP and hs-troponin I and other biomarkers in the prognosis of symptomatic carotid stenosis. Imagiologic markers are to be included - intima-media; gray weale plaque classification, cerebral CT Peak wave velocity

Official Title
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Clinical, Hematological, and Imagiologic Predictors of Postoperative Complications and Long Term Cardiovascular Events After Carotid Endarterectomy With Regional Anesthesia

Conditions
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Carotid Stenosis, Carotid Endarterectomy

Intervention / Treatment
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* Diagnostic Test: Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia Exclusion Criteria: general anesthesia carotid stenting

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Carotid endarterectomy<br>This study is a non-interventional prospective cohort study. The population corresponds to patients submitted to CEA under regional anesthesia. Consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) will be prospectively recruited. The expected patient follow-up will be of 5 years. The demographics will be recorded in a prospective, protected database. Blood samples will be collected in clot activator serum tubes at three timepoints: timepoint 1 - before surgery (until 15 days before surgery); timepoint 2 up to 48h postoperatively; timepoint | Diagnostic Test: Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP<br>* peak wave velocity; gray weale plaque classification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke |  | 30 days, long-term | 
| Clavien dindo>3 |  | 30 days, long-term | 
| MACE | AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality | 30 days, long-term |