Clinical trial NCT05623293: Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis
Official title: Prognostic Predictors of Cardiovascular and Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis Undergoing Carotid Endarterectomy With Regional Anesthesia - A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Choroid Disease
Carotid Stenosis
Carotid Atherosclerosis
Retinal Disease
Keywords: Carotid endarterectomy
Optimal coherence tomography,
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Hospital Sao Joao
First posted: 2022-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a non-interventional prospective cohort study. The 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 w year

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.

Eligibility criteria: Inclusion Criteria:

* Consecutive carotid stenosis

Exclusion Criteria:

* blind patients
* Radic stenosis

Primary outcomes:
measure: Stroke
timeFrame: 30 days
measure: optical coherence tomography - Angio
timeFrame: 15 days before surgery
measure: optical coherence tomography - Angio
timeFrame: 24h after surgery
measure: optical coherence tomography - Angio
timeFrame: 30 days after surgery
measure: optical coherence tomography - Angio
timeFrame: one year after surgery
Secondary outcomes:
measure: Restenosis
timeFrame: 2 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Joao Rocha-Neves
Study officials:
References:
citation: Nakazawa T. Ocular Blood Flow and Influencing Factors for Glaucoma. Asia Pac J Ophthalmol (Phila). 2016 Jan-Feb;5(1):38-44. doi: 10.1097/APO.0000000000000183.