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Clinical Trials/NCT05623293
NCT05623293
Recruiting
Not Applicable

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

Universidade do Porto1 site in 1 country40 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Choroid Disease
Sponsor
Universidade do Porto
Enrollment
40
Locations
1
Primary Endpoint
optical coherence tomography - Angio
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

João Rocha Neves

Principal Investigator

Universidade do Porto

Eligibility Criteria

Inclusion Criteria

  • Consecutive carotid stenosis

Exclusion Criteria

  • blind patients
  • Radic stenosis

Outcomes

Primary Outcomes

optical coherence tomography - Angio

Time Frame: one year after surgery

Vessel density and distribution

Stroke

Time Frame: 30 days

diagnosed by Computer tomography and clinical examation

Secondary Outcomes

  • Restenosis(2 months)

Study Sites (1)

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