- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03313817
Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO) (I-RECANAL)
Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke at the retinal level. They share the same risk factors and common pathology. The diagnosis of a CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia.
Small studies have highlighted the value of cerebral MRI (Magnetic Resonance Imaging) in CRAO with almost 25% of ischemic strokes found on diffusion sequences and the demonstration of a correlation between anomalies in diffusion sequence and the probability of a pathology with a high risk of recurrence (carotid stenosis or emboligenic cardiopathy). But there are usually few radiological signs that allow a direct positive diagnosis of CRAO, an etiologic diagnosis or a prognosis. This descriptive study will focus on CRAO at the diagnostic and post-treatment phases in the short and medium term, in order to (i) identify imaging etiologic signs of CRAO with specific sequences from a 3 Tesla MRI, (ii) identify positive diagnostic signs of CRAO with the same specific sequences, (iii) correlate these signs with the visual prognosis one month after the CRAO.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France
- Fondation Ophtalmologique A. De Rothschild
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- CRAO (onset of symptoms ≤ 48 hours)
- Consent to participate in the study
Exclusion Criteria:
- Contraindications to 3 Tesla MRI
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Contrast enhancement of the ophthalmic artery
Time Frame: Baseline
|
Binary variable (yes/no)
|
Baseline
|
|
Presence of a thrombus
Time Frame: Baseline
|
Binary variable (yes/no)
|
Baseline
|
|
Presence of an arterial stenosis of the supra aortic trunks
Time Frame: Baseline
|
Binary variable (yes/no)
|
Baseline
|
|
Hypersignal of the ophthalmic artery in diffusion
Time Frame: Baseline
|
Binary variable (yes/no)
|
Baseline
|
|
Restriction of the apparent diffusion coefficient (ADC) at the optic nerve level and at the papilla level
Time Frame: Baseline
|
Binary variable (yes/no)
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALR_2017_17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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