Condition or disease | Intervention/treatment |
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Carotid Artery Injuries | Diagnostic Test: OCT-angiography and SD-OCT |
The stenosis of the internal carotid artery is a frequent and potentially serious pathology (TIA, ischemic stroke, death), which can also be manifested by ophthalmological charts, foremost among which are transient monocular blindness.
The most common etiology of this stenosis remains the atheromatous pathology, whose treatment, depending on the symptomatic or non-symptomatic nature of the stenosis, includes, among other things, a revascularization procedure that may be surgical (endarterectomy, reference treatment) or guided by radiology (angioplasty and carotid stent placement)
From the anatomical point of view, the internal carotid artery notably has for branching the ophthalmological artery, which itself will give birth:
Very little knowledge at the present time relates changes in retinal and choroidal vascularization after a revascularization procedure on the internal carotid artery OCT-angiography is a non-invasive imaging technique that is now part of investigative examinations in retinal imaging. This technique makes it possible to study the macular and choroidal retinal vascularization with precision without injection of contrast medium and thus allows to deepen the knowledge in medical fields where the exploration was until now limited because of the invasiveness of the examinations.
The hypothesis of this project is that revascularization of the internal carotid artery would improve retinal and choroidal ipsilateral perfusion in the short term (1 month postoperatively), as assessed by OCT-angiography. OCT-angiography could also be used to assess retinal and choroidal embolism risk, usually recognized as increased in cases of symptomatic or asymptomatic carotid stenosis.
Study Type : | Observational |
Estimated Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Multimodal Imaging Analysis, OCT-angiography (Optical Coherence Tomography) and SD-OCT (Spectral Domain Optical Coherence Tomography), of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery |
Estimated Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | June 1, 2020 |
Estimated Study Completion Date : | June 1, 2021 |
Tracking Information | |||||
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First Submitted Date | May 3, 2019 | ||||
First Posted Date | May 6, 2019 | ||||
Last Update Posted Date | May 6, 2019 | ||||
Estimated Study Start Date | June 1, 2019 | ||||
Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
homolateral retinal and choroidal vascular density (%) [ Time Frame: 1 month ] Finely describe the homolateral retinal and choroidal vascular density changes in the macula in OCT-angiography at 1 month after revascularization on the internal carotid artery
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery | ||||
Official Title | Multimodal Imaging Analysis, OCT-angiography (Optical Coherence Tomography) and SD-OCT (Spectral Domain Optical Coherence Tomography), of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery | ||||
Brief Summary | The purpose of this study is to describe the changes in morphology and Retinal vascularization after revascularization of the internal carotid artery. Indeed, the stenosis of the internal carotid artery can lead to ophthalmological charts. The underlying hypothesis is that revascularization of the internal carotid artery would improve ipsilateral and retinal homolateral perfusion in the short term. The OCT-angiography technique accurately studies the retinal vasculature and also assesses the risk of retinal and choroidal embolism, which is recognized as increased in cases of symptomatic or asymptomatic carotid stenosis. | ||||
Detailed Description |
The stenosis of the internal carotid artery is a frequent and potentially serious pathology (TIA, ischemic stroke, death), which can also be manifested by ophthalmological charts, foremost among which are transient monocular blindness. The most common etiology of this stenosis remains the atheromatous pathology, whose treatment, depending on the symptomatic or non-symptomatic nature of the stenosis, includes, among other things, a revascularization procedure that may be surgical (endarterectomy, reference treatment) or guided by radiology (angioplasty and carotid stent placement) From the anatomical point of view, the internal carotid artery notably has for branching the ophthalmological artery, which itself will give birth:
Very little knowledge at the present time relates changes in retinal and choroidal vascularization after a revascularization procedure on the internal carotid artery OCT-angiography is a non-invasive imaging technique that is now part of investigative examinations in retinal imaging. This technique makes it possible to study the macular and choroidal retinal vascularization with precision without injection of contrast medium and thus allows to deepen the knowledge in medical fields where the exploration was until now limited because of the invasiveness of the examinations. The hypothesis of this project is that revascularization of the internal carotid artery would improve retinal and choroidal ipsilateral perfusion in the short term (1 month postoperatively), as assessed by OCT-angiography. OCT-angiography could also be used to assess retinal and choroidal embolism risk, usually recognized as increased in cases of symptomatic or asymptomatic carotid stenosis. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | The study will be proposed to patients for whom revascularization has been performed by vascular surgeons (symptomatic, asymptomatic carotid stenosis) | ||||
Condition | Carotid Artery Injuries | ||||
Intervention | Diagnostic Test: OCT-angiography and SD-OCT
Performing an OCT-angiography and SD-OCT examination
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Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
30 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | June 1, 2021 | ||||
Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03939351 | ||||
Other Study ID Numbers | CAROCT-A 2018-A00777-48 ( Other Identifier: ID-RCB ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Centre Hospitalier Intercommunal Creteil | ||||
Study Sponsor | Centre Hospitalier Intercommunal Creteil | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Centre Hospitalier Intercommunal Creteil | ||||
Verification Date | June 2018 |