Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO)

Magnetic Resonance Imaging Clinical Trial

— I-RECANAL  

Official title:

Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03313817
• Other study ID #: ALR_2017_17
• Status: Recruiting
• Start date: December 13, 2017
• Est. completion date: March 2024

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Laurence Salomon, MD PhD
• Phone: 0148036431
• Email: lsalomon[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Diagnosis
• Etiology
• Magnetic Resonance Imaging
• Prognosis
• Retinal Artery Occlusion

Intervention

Device:
• Additional MRI sequences
Patients will be hospitalized for suspicion of CRAO. An "optimized" MRI will be performed with specific sequences: 3D T1 MSDE (Motion Sensitized Driven Equilibrium) "dark blood"; 3D Optimized diffusion centered on the optic nerves; 3D PD T1 after injection. A consultation of ophthalmology and a control MRI will be carried out one month after the CRAO. Again, specific sequences will be added: 3D T1 MSDE (Motion Sensitized Driven Equilibrium) "dark blood"; 3D Optimized diffusion centered on the optic nerves; DTI (Diffusion Tensor Imaging); 3D PD T1 after injection.

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast enhancement of the ophthalmic artery	Binary variable (yes/no)	Baseline
Primary	Presence of a thrombus	Binary variable (yes/no)	Baseline
Primary	Presence of an arterial stenosis of the supra aortic trunks	Binary variable (yes/no)	Baseline
Primary	Hypersignal of the ophthalmic artery in diffusion	Binary variable (yes/no)	Baseline
Primary	Restriction of the apparent diffusion coefficient (ADC) at the optic nerve level and at the papilla level	Binary variable (yes/no)	Baseline