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Multimodal Retinal Imaging of Cerebrovascular Stroke (OCTAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964610
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

The hypothesis is that in patients with stroke, abnormalities of retinal microvascularization shown on color fundus photography and the depletion of retinal capillary density evaluated by OCT-A are markers of acute impairment of microcirculation of the central nervous system and are correlated with lesions on brain imaging.

Patients hospitalized for stroke MRI-confirmed, will be included. An ophthalmologic assessment including color fundus photography (CFP) and OCT-A will be carried out after stabilization and at 3 months follow-up. Outcomes assessor will be blinded.


Condition or disease Intervention/treatment
Stroke Cerebrovascular Accidents Diagnostic Test: color fundus photography (CFP) and OCT-A

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Retinal Imaging of Cerebrovascular Stroke
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : February 15, 2021

Intervention Details:
  • Diagnostic Test: color fundus photography (CFP) and OCT-A
    Included patients will have an ophthalmologic assessment (OCT-A and CPF) after stabilization and at 3 months follow-up.


Primary Outcome Measures :
  1. Presence of an anomaly in color fundus photography or an anomaly of retinal capillary density to OCT-A [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute patients with a stroke will be included
Criteria

Inclusion criteria:

  • Acute ischemic stroke
  • With cerebral microangiopathy (defined by a SVD score > 1)

Exclusion criteria:

  • Acute hemorrhagic stroke
  • Anophthalmia

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): NCT03964610


Contacts
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Contact: Rabih Hage +33148036568 rhage@for.paris
Contact: Amélie Yavchitz +33148036454 ayavchitz@for.paris

Locations
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France
Fondation A de Rothschild Recruiting
Paris, France, 75019
Contact: Rabih HAGE, MD       rhage@for.paris   
Contact: Nicolas VIDALIE       nvidalie@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03964610    
Other Study ID Numbers: RHE_2019_10
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
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
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
optical coherence tomography (OCT-A)
color fundus photography (CFP)
Retinal microvascularization
Cerebral microangiopathy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases