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Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05623293
Enrollment
40
Registered
2022-11-21
Start date
2022-01-01
Completion date
2023-12-31
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Atherosclerosis, Carotid Stenosis, Choroid Disease, Retinal Disease

Keywords

Carotid endarterectomy, Optimal coherence tomography,

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.

Interventions

DIAGNOSTIC_TESTeye - Optcial coherence tomography

pre and postoperative

Sponsors

Hospital Sao Joao
CollaboratorOTHER
Universidade do Porto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consecutive carotid stenosis

Exclusion criteria

* blind patients * Radic stenosis

Design outcomes

Primary

MeasureTime frameDescription
Stroke30 daysdiagnosed by Computer tomography and clinical examation
optical coherence tomography - Angio15 days before surgeryVessel density and distribution

Secondary

MeasureTime frameDescription
Restenosis2 monthsultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s

Countries

Portugal

Contacts

Primary ContactJoao Rocha-Neves, MD, MPH
joaorochaneves@hotmail.com+351910486230

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026