NCT05623293

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

August 15, 2021

Last Update Submit

November 14, 2022

Conditions

Choroid DiseaseCarotid StenosisCarotid AtherosclerosisRetinal Disease

Keywords

Carotid endarterectomyOptimal coherence tomography,

Outcome Measures

Primary Outcomes (5)

  • Stroke

    diagnosed by Computer tomography and clinical examation

    30 days

  • optical coherence tomography - Angio

    Vessel density and distribution

    15 days before surgery

  • optical coherence tomography - Angio

    Vessel density and distribution

    24h after surgery

  • optical coherence tomography - Angio

    Vessel density and distribution

    30 days after surgery

  • optical coherence tomography - Angio

    Vessel density and distribution

    one year after surgery

Secondary Outcomes (1)

  • Restenosis

    2 months

Study Arms (1)

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

Interventions

eye - Optcial coherence tomographyDIAGNOSTIC_TEST

pre and postoperative

Carotid endarterectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Consecutive carotid stenosis

You may not qualify if:

  • blind patients
  • Radic stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joao Rocha-Neves

Porto, 4200-319, Portugal

RECRUITING

Related 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.

    PMID: 26886118BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Choroid DiseasesCarotid StenosisCarotid Artery DiseasesRetinal Diseases

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Joao Rocha-Neves, MD, MPH

CONTACT

+351910486230joaorochaneves@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2021

First Posted

November 21, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Publications

Locations

PT(1)