Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis

Study Overview
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Brief Summary
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The retinal vessels have been shown to reflect vascular changes inherent to systemic pathologies, even when no ocular disease is identified. As such, the eye's vasculature is ableto serve as a window to the vascular health of the human body and a means of assessing systemic endothelial function. Optical coherence tomography angiography (OCTA) employs optical means to image all the retinal vascular layers and the choroid, providing an extremely detailed image of the microvascular network in a fast, reproducible and totally non-invasive way. As such, it is currently the best non-invasive way of having an image of human capillaries. Recently, OCTA has been used to study the retinal vessels' structure and function in several cardiovascular diseases. As an example of its predictive potential, reduced retinal microvascular density has been associated with the cardiovascular risk profile in patients admitted to the hospital for an acute coronary syndrome. Recent studies have also shown the retinal microvasculature density to be reduced in patients with carotid artery disease (CAD), namely carotid stenosis, and that endarterectomy increases retinal flow and vessel density.

Detailed Description
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The authors hypothesize that FGF-23, GDF-15, VEGF-A, MMP-9 and retinal/choroidal microvascular density could predict cerebral ischemia, postoperative complications, long term major cardiovascular events and short term ophthalmologic alterations particularly in patients developing symptomatic neurologic ischemia after circulation shutdown. The purpose of this study is to compare different cardiac risk scores in carotid endarterectomy. The main aim of this study is to test the risk factors individually and determine its discriminatory ability. Combinations of traditional preoperative risk factors and scores will be evaluated to enhance the assessment of major adverse cardiac events in vascular surgery patients. Establish and validate biomarkers that improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

Official Title
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Prognostic Predictors of Cardiovascular and Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis Undergoing Carotid Endarterectomy With Regional Anesthesia - A Prospective Study

Conditions
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Choroid Disease, Carotid Stenosis, Carotid Atherosclerosis, Retinal Disease

Intervention / Treatment
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* Diagnostic Test: eye - Optcial coherence tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive carotid stenosis Exclusion Criteria: blind patients Radic stenosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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>he population corresponds to patients submitted to elective CEA. Consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia will be prospectively recruited from September 2021 - December 2022. The expected patient follow-up will be of 2years. | Diagnostic Test: eye - Optcial coherence tomography<br>* pre and postoperative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | diagnosed by Computer tomography and clinical examation | 30 days | 
| optical coherence tomography - Angio | Vessel density and distribution | 15 days before surgery | 
| optical coherence tomography - Angio | Vessel density and distribution | 24h after surgery | 
| optical coherence tomography - Angio | Vessel density and distribution | 30 days after surgery | 
| optical coherence tomography - Angio | Vessel density and distribution | one year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis | ultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid endarterectomy, Optimal coherence tomography,