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Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery (CAROCT-A)

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ClinicalTrials.gov Identifier: NCT03939351
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

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.

Condition or disease Intervention/treatment
Carotid Artery Injuries Diagnostic Test: OCT-angiography and SD-OCT

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:

  • at the central artery of the retina: role in the vascularization of the inner layers of the retina
  • posterior ciliary arteries: role in the choroidal vasculature and outer layers of the retina.

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
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

Intervention Details:
  • Diagnostic Test: OCT-angiography and SD-OCT
    Performing an OCT-angiography and SD-OCT examination


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Vascular density of contralateral eye (%) [ Time Frame: 1 month ]
    Describe the variations of vascular density in OCT-A on the controlateral eye after revascularization

  2. Subfoveal choroidal thickness [ Time Frame: 1 month ]
    Describe the variations of subfoveal choroidal thickness in OCT-EDI (Enhanced depth imaging optical coherence tomography) after revascularization

  3. Optical fiber thickness [ Time Frame: 1 month ]
    Describe the variations in homolateral optical fiber thickness in RNFL ( Retinal Nerve Fiber Layer)OCT after revascularization

  4. retinal and choroidal vascular density (%) [ Time Frame: 1 month ]
    Compare the retinal and choroidal variations according to the proposed procedure: conventional surgery or angioplasty and stenting

  5. Intraocular pressure (mm Hg) [ Time Frame: 1 month ]
    Compare changes in intraocular pressure before and after revascularization procedure

  6. Retinal and choroidal vascular density (%) according to the type of carotid stenosis [ Time Frame: 1 month ]
    Compare changes in retinal and choroidal vascular density according to the type of carotid stenosis: symptomatic stenosis, asymptomatic stenosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

Inclusion Criteria

  • Patient aged 18 or over
  • Indication of treatment with a carotid revascularization procedure (conventional surgery or angioplasty and stent)
  • Acceptance to participate in the protocol

Exclusion Criteria:

  • Associated retinal ophthalmological pathology: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, CRSC (Central serous chorioretinopathy)
  • Refusal to participate in the study
  • Not affiliated to a social security scheme

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939351


Contacts
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Contact: Camille JUNG, MD 0033157022268 camille.jung@chicreteil.fr

Locations
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France
CHU Henri-Mondor
Créteil, France, 94000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil

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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03939351     History of Changes
Other Study ID Numbers: CAROCT-A
2018-A00777-48 ( Other Identifier: ID-RCB )
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carotid Artery Injuries
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries