Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging

NCT ID: NCT03265860

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 274 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-10
• Study Completion Date: 2021-06-14

Brief Summary

Ischemic strokes are the first cause of handicap in adult people, the second cause of dementia and the third cause of death in France. Brain Magnetic Resonance (MR) initial assessment is mandatory to get the right diagnosis, to exclude hemorrhagic lesions and to determine the best treatment.

The conventional diffusion weighted imaging sequence is used to establish the diagnosis and to estimate the volume of ischemic lesions. The perfusion weighted imaging sequences are also used to assess the diffusion-perfusion mismatch which is supposed to be the ischemic penumbra corresponding to territories that could be saved with appropriate treatments.

IntraVoxel Incoherent Motion (IVIM) is a multi-b diffusion sequence which allows to extract four quantitative variables (D, D*, f, ADC) related to the true molecular diffusion and correlated to the microvascular perfusion.

It's a quick sequence with no need of contrast injection and allowing a perfect coregistration with the true diffusion. It has been validated in many pathologies but not in acute strokes.

The feasibility of this sequence in acute ischemic strokes has already been assessed with interesting results.

The study aims to assess the correlation between the quantitative values of IVIM at initial MR exam and the modified Rankin Scale (mRS) score 3 months after an acute ischemic stroke.

Conditions

Stroke; Magnetic Resonance Imaging

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

IntraVoxel Incoherent Motion sequence

The IVIM diffusion sequence with a duration of 2 minutes is added to the imaging protocol.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients
• Admitted for an acute ischemic stroke
• Affiliated to a Social Security scheme

Exclusion Criteria

• Absolute contraindications to MRI
• Pregnant or breastfeeding woman

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Augustin Lecler, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique A. de Rothschild

Locations

Fondation Ophtalmologique A. de Rothschild

Paris, , France

Countries

France

Other Identifiers

ALR_2017_5

Identifier Type: -

Identifier Source: org_study_id