Automated Volume Assessment of Acute Stroke (AVAAS)

Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

406

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75019
        • Fondation A de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

we will include all adult patient with ischemic stroke which have MRI for stroke diagnosis

Description

Inclusion Criteria:

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

Non inclusion criteria :

  • Pregnant or breastfeeding women
  • Patients with absolute contraindications to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ischemic stroke
all patients with a suspicion of ischemic stroke
MRI with B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automated volume assessment of acute stroke
Time Frame: 1 hour

Our objective is to compare several volumetric techniques (manual, semi-manual, automatic) based on the B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion.

We will also evaluate the correlation between the volumes obtained by the different techniques and the final volume of FLAIR infarction and diffusion in a subgroup of patients for whom a follow-up MRI is feasible.

1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2018

Primary Completion (ACTUAL)

September 4, 2020

Study Completion (ACTUAL)

December 4, 2020

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (ACTUAL)

August 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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