NCT03964610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 3, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

May 24, 2019

Last Update Submit

March 2, 2022

Conditions

StrokeCerebrovascular Accidents

Keywords

optical coherence tomography (OCT-A)color fundus photography (CFP)Retinal microvascularizationCerebral microangiopathy

Outcome Measures

Primary Outcomes (1)

  • Presence of an anomaly in color fundus photography or an anomaly of retinal capillary density to OCT-A

    3 months

Interventions

color fundus photography (CFP) and OCT-ADIAGNOSTIC_TEST

Included patients will have an ophthalmologic assessment (OCT-A and CPF) after stabilization and at 3 months follow-up.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute patients with a stroke will be included

You may qualify if:

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

You may not qualify if:

  • Acute hemorrhagic stroke
  • Anophthalmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

StrokeCerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 28, 2019

Study Start

November 15, 2019

Primary Completion

November 15, 2021

Study Completion

February 15, 2022

Last Updated

March 3, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)