Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623293
• Other study ID #: 163-21
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Universidade do Porto
• Contact: Joao Rocha-Neves, MD, MPH
• Phone: +351910486230
• Email: joaorochaneves[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive carotid stenosis

Exclusion Criteria:

• blind patients

• Radic stenosis

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Carotid Stenosis
• Choroid Disease
• Constriction, Pathologic
• Retinal Disease
• Retinal Diseases

Intervention

Diagnostic Test:
• eye - Optcial coherence tomography
pre and postoperative

Locations

Country	Name	City	State
Portugal	Joao Rocha-Neves	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	Hospital Sao Joao

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke	diagnosed by Computer tomography and clinical examation	30 days
Primary	optical coherence tomography - Angio	Vessel density and distribution	15 days before surgery
Primary	optical coherence tomography - Angio	Vessel density and distribution	24h after surgery
Primary	optical coherence tomography - Angio	Vessel density and distribution	30 days after surgery
Primary	optical coherence tomography - Angio	Vessel density and distribution	one year after surgery
Secondary	Restenosis	ultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s	2 months