Automated Volume Assessment of Acute Stroke

NCT ID: NCT03618251

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

406 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-15

Study Completion Date

2020-12-04

Brief Summary

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Stroke is a common disease. It is increasingly managed in non-specialized centers.

The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.

There is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.

The Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.

Manual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.

Detailed Description

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Conditions

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Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ischemic stroke

all patients with a suspicion of ischemic stroke

specific MRI sequences

Intervention Type DIAGNOSTIC_TEST

MRI with B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion

Interventions

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specific MRI sequences

MRI with B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients admitted for a recent neurological deficit (less than 24 hours), suspected for a stroke.


* Pregnant or breastfeeding women
* Patients with absolute contraindications to MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation A De Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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FCD_2017_20

Identifier Type: -

Identifier Source: org_study_id

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