Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis

Sponsor
Universidade do Porto (Other)
Overall Status
Recruiting
CT.gov ID
NCT05623293
Collaborator
Hospital Sao Joao (Other)
40
1
24
1.7

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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 :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Stroke [30 days]

    diagnosed by Computer tomography and clinical examation

  2. optical coherence tomography - Angio [15 days before surgery]

    Vessel density and distribution

  3. optical coherence tomography - Angio [24h after surgery]

    Vessel density and distribution

  4. optical coherence tomography - Angio [30 days after surgery]

    Vessel density and distribution

  5. optical coherence tomography - Angio [one year after surgery]

    Vessel density and distribution

Secondary Outcome Measures

  1. Restenosis [2 months]

    ultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Consecutive carotid stenosis
Exclusion Criteria:
  • blind patients

  • Radic stenosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Joao Rocha-Neves Porto Portugal 4200-319

Sponsors and Collaborators

  • Universidade do Porto
  • Hospital Sao Joao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
João Rocha Neves, Principal Investigator, Universidade do Porto
ClinicalTrials.gov Identifier:
NCT05623293
Other Study ID Numbers:
  • 163-21
First Posted:
Nov 21, 2022
Last Update Posted:
Nov 21, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by João Rocha Neves, Principal Investigator, Universidade do Porto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2022