Choroid DiseaseNCT05623293
Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis
An observational study of Choroid Disease and Carotid Stenosis, run by Universidade do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroid Disease, Carotid Stenosis, Carotid Atherosclerosis
- What is being tested?
- eye - Optcial coherence tomography
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Consecutive carotid stenosis
Who cannot join
- blind patients
- Radic stenosis
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Joao Rocha-Neves
Porto, 4200-319
Joao Rocha-Neves, 910486230, joaorochaneves@hotmail.com
About this study
Official title: Prognostic Predictors of Cardiovascular and Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis Undergoing Carotid Endarterectomy With Regional Anesthesia - A Prospective Study
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.
Read the 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.
- Being tested
- eye - Optcial coherence tomography
- Keywords
- Carotid endarterectomy, Optimal coherence tomography,
- Medical subject headings
- Choroid Diseases, Carotid Stenosis, Carotid Artery Diseases, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye - Optcial coherence tomographyDiagnostic test
pre and postoperative
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: eye - Optcial coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
diagnosed by Computer tomography and clinical examation
Measured: 30 days
optical coherence tomography - Angio
Vessel density and distribution
Measured: 15 days before surgery
optical coherence tomography - Angio
Vessel density and distribution
Measured: 24h after surgery
optical coherence tomography - Angio
Vessel density and distribution
Measured: 30 days after surgery
optical coherence tomography - Angio
Vessel density and distribution
Measured: one year after surgery
Secondary outcomes (1)
Restenosis
ultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Choroid DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sao Joao
- Responsible party
- Principal investigator, João Rocha Neves, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623293
- Sponsor's protocol ID
- 163-21
- Status last verified
- Nov 2022
- First submitted
- 15 Aug 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publications
Publications
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.
PubMed 26886118
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Predictors of Cardiovascular and Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis Undergoing Carotid Endarterectomy With Regional Anesthesia - A Prospective Study
- ClinicalTrials.gov ID
- NCT05623293
- Acronym / sponsor ID
- 163-21
- Keywords
- Carotid endarterectomy, Optimal coherence tomography,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Hospital Sao Joao
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy | – | Diagnostic Test: eye - Optcial coherence tomographyhe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Consecutive carotid stenosis
Key exclusion criteria (2 listed)
- blind patients
- Radic stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye - Optcial coherence tomographypre and postoperative | Diagnostic test | Carotid endarterectomy |
Primary outcome
Stroke
Time frame: 30 days
diagnosed by Computer tomography and clinical examation
optical coherence tomography - Angio
Time frame: 15 days before surgery
Vessel density and distribution
optical coherence tomography - Angio
Time frame: 24h after surgery
Vessel density and distribution
optical coherence tomography - Angio
Time frame: 30 days after surgery
Vessel density and distribution
optical coherence tomography - Angio
Time frame: one year after surgery
Vessel density and distribution
1 secondary outcome
Restenosis
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 26886118Nakazawa 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.
- Individual participant dataSharing planned: No. Publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroid Disease and Carotid Stenosis, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joao Rocha-Neves, MD, MPH (+351910486230, joaorochaneves@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05623293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.