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Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05623293
Recruitment Status : Recruiting
First Posted : November 21, 2022
Last Update Posted : November 21, 2022
Sponsor:
Collaborator:
Hospital Sao Joao
Information provided by (Responsible Party):
João Rocha Neves, Universidade do Porto

Study Description
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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.

Condition or disease Intervention/treatment
Choroid Disease Carotid Stenosis Carotid Atherosclerosis Retinal Disease Diagnostic Test: eye - Optcial coherence tomography

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Predictors of Cardiovascular and Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis Undergoing Carotid Endarterectomy With Regional Anesthesia - A Prospective Study
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Carotid endarterectomy
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.
 Diagnostic Test: eye - Optcial coherence tomography
pre and postoperative


Outcome Measures
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Primary Outcome Measures :
  1. Stroke [ Time Frame: 30 days ]
    diagnosed by Computer tomography and clinical examation

  2. optical coherence tomography - Angio [ Time Frame: 15 days before surgery ]
    Vessel density and distribution

  3. optical coherence tomography - Angio [ Time Frame: 24h after surgery ]
    Vessel density and distribution

  4. optical coherence tomography - Angio [ Time Frame: 30 days after surgery ]
    Vessel density and distribution

  5. optical coherence tomography - Angio [ Time Frame: one year after surgery ]
    Vessel density and distribution


Secondary Outcome Measures :
  1. Restenosis [ Time Frame: 2 months ]
    ultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s


Biospecimen Retention:   Samples With DNA
blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Consecutive carotid stenosis

Exclusion Criteria:

  • blind patients
  • Radic stenosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05623293


Contacts
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Contact: Joao Rocha-Neves, MD, MPH +351910486230 joaorochaneves@hotmail.com

Locations
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Portugal
Joao Rocha-Neves Recruiting
Porto, Portugal, 4200-319
Contact: Joao Rocha-Neves    910486230    joaorochaneves@hotmail.com   
Sponsors and Collaborators
Universidade do Porto
Hospital Sao Joao
More Information
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Publications:

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Responsible Party: João Rocha Neves, Principal Investigator, Universidade do Porto
ClinicalTrials.gov Identifier: NCT05623293    
Other Study ID Numbers: 163-21
First Posted: November 21, 2022    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Publications

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by João Rocha Neves, Universidade do Porto:
Carotid endarterectomy
Optimal coherence tomography,
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Retinal Diseases
Choroid Diseases
Atherosclerosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Uveal Diseases