Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis

Recruiting

• Conditions: Choroid Disease; Carotid Atherosclerosis; Retinal Disease; Carotid Stenosis
• Interventions: Diagnostic Test: eye - Optcial coherence tomography

• Registration Number: NCT05623293
• Lead Sponsor: Universidade do Porto

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-08-15
• Study Start: 2022-01-01
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study First Posted: 2022-11-21
• Last Update Posted: 2022-11-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Consecutive carotid stenosis

Exclusion Criteria

• blind patients
• Radic stenosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid endarterectomy	eye - Optcial coherence tomography	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.

Primary Outcome Measures

Name	Time	Method
optical coherence tomography - Angio	one year after surgery	Vessel density and distribution
Stroke	30 days	diagnosed by Computer tomography and clinical examation

Secondary Outcome Measures

Name	Time	Method
Restenosis	2 months	ultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s

Trial Locations

Locations (1)

Joao Rocha-Neves; 🇵🇹 Porto, Portugal