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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery

Clinicaltrials.gov identifier NCT03939351

Recruitment Status Not yet recruiting

First Posted May 6, 2019

Last update posted May 6, 2019

Study Description

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:Carotid Artery Injuries
  • Intervention/Treatment: Diagnostic Test: OCT-angiography and SD-OCT
  • Phase: N/A
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.

Study Design
  • 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 2019
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: June 2021
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • 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

Contacts and Locations
Contacts

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

Locations

France
CHU Henri-Mondor
Créteil

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

More Information
  • Responsible Party: Centre Hospitalier Intercommunal Creteil
  • ClinicalTrials.gov Identifier: NCT03939351 History of Changes
  • Other Study ID Numbers: CAROCT-A, 2018-A00777-48
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carotid Artery Injuries