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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03313817
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Anticipated Duration (Months): 62.6
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Artery Occlusion; Magnetic Resonance Imaging; Diagnosis; Etiology; Prognosis	Device: Additional MRI sequences

Study Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO)
• Actual Study Start Date: Dec 13, 2017
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Outcome Measures

Primary Outcome Measures

1. Contrast enhancement of the ophthalmic artery [Baseline]

   Binary variable (yes/no)

2. Presence of a thrombus [Baseline]

   Binary variable (yes/no)

3. Presence of an arterial stenosis of the supra aortic trunks [Baseline]

   Binary variable (yes/no)

4. Hypersignal of the ophthalmic artery in diffusion [Baseline]

   Binary variable (yes/no)

5. Restriction of the apparent diffusion coefficient (ADC) at the optic nerve level and at the papilla level [Baseline]

   Binary variable (yes/no)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmologique A. de Rothschild	Paris		France

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT03313817
• Other Study ID Numbers: ALR_2017_17
• First Posted: Oct 18, 2017
• Last Update Posted: Apr 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Retinal Artery Occlusion; Arterial Occlusive Diseases

Study Results

No Results Posted as of Apr 8, 2022