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

Stroke Clinical Trial

— IMPROVES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265860
• Other study ID #: ALR_2017_5
• Status: Completed
• Start date: August 10, 2017
• Est. completion date: June 14, 2021

Study information

• Verified date: May 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: June 14, 2021
• Est. primary completion date: March 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Stroke

Intervention

Device:
• IntraVoxel Incoherent Motion sequence
The IVIM diffusion sequence with a duration of 2 minutes is added to the imaging protocol.

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between quantitative values of IntraVoxel Incoherent Motion at initial Magnetic Resonance Imaging (MRI) and the modified Rankin Scale (mRS) at 3 months after an acute ischemic stroke.	IntraVoxel Incoherent Motion is a 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.; We aim to assess the correlation between the quantitative values of IVIM at initial exam and the mRS score 3 months after an acute ischemic stroke.	3 months