Carotid StenosisCAS-AOCTNCT05835869
Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization
A study testing Optical coherence tomography angiography and pattern electroretinogram in people with Carotid Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Optical coherence tomography angiography and pattern electroretinogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2023to 30 Apr 2024
- Phase
- Interventional
- 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
Who may be able to join
- age >18 years old
- Carotid stenosis diagnosis with indication to perform carotid endarterectomy
- informed consent form signing
Who cannot join
- age <18 years old
- recurrent intraocular inflammation
- retinal disease
- optic neuropathy, optic nerve drusen, opacity of the dioptric means in the pre- or post-operative period that prevents the acquisition of high-resolution images
- unstable fixation
- spheric refractive error > +/- 6 D spheric and/or +/- 3 D cylinder
- history of prior ocular surgery
- refusal of signing informed consent form
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Agostino Gemelli IRCCS
Roma, RM, 00168
Antonio Baldascino, MD, +393388771472, antonio.baldascino@policlinicogemelli.it
About this study
Official title: Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study
The aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery.
- Conditions
- Carotid Stenosis
- Being tested
- Optical coherence tomography angiography and pattern electroretinogram
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiography and pattern electroretinogramDiagnostic test
Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy
| Study group | Role | What they receive |
|---|---|---|
| Study population | Experimental | Not described Receives: Diagnostic Test: Optical coherence tomography angiography and pattern electroretinogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional retinal changes
To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy
Measured: 1 week and 3 months
Secondary outcomes (1)
Retinal vascular density changes
To evaluate rate of chorioretinal vascular density improvement trough angiographic optical coherence tomography before and after carotid endarterectomy
Measured: 1 week and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start20 Apr 2023
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Baldascino, MD, Principal investigator, Policlinico Agostino Gemelli IRRCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835869
- Sponsor's protocol ID
- 5532
- Acronym
- CAS-AOCT
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study
- ClinicalTrials.gov ID
- NCT05835869
- Acronym / sponsor ID
- CAS-AOCT / 5532
- Conditions
- Carotid Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 28 Apr 2023 (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 aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Diagnostic Test: Optical coherence tomography angiography and pattern electroretinogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >18 years old
- Carotid stenosis diagnosis with indication to perform carotid endarterectomy
- informed consent form signing
Key exclusion criteria (8 listed)
- age <18 years old
- recurrent intraocular inflammation
- retinal disease
- optic neuropathy, optic nerve drusen, opacity of the dioptric means in the pre- or post-operative period that prevents the acquisition of high-resolution images
- unstable fixation
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 |
|---|---|---|
| Optical coherence tomography angiography and pattern electroretinogramOptical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy | Diagnostic test | Study population |
Primary outcome
Functional retinal changes
Time frame: 1 week and 3 months
To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy
1 secondary outcome
Retinal vascular density changes
Time frame: 1 week and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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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.
Antonio Baldascino, MD principal investigator
Policlinico Agostino Gemelli IRRCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherence tomography angiography and pattern electroretinogram in people with Carotid Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 8 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 6 Jul 2023. 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 Italy. 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 Antonio Baldascino, MD (+393388771472, antonio.baldascino@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional retinal changes (time frame: 1 week and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2023.