Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging (IMPROVES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03265860|
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : February 8, 2018
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.
|Condition or disease||Intervention/treatment|
|Stroke Magnetic Resonance Imaging||Device: IntraVoxel Incoherent Motion sequence|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging|
|Actual Study Start Date :||August 10, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
- Device: IntraVoxel Incoherent Motion sequence
The IVIM diffusion sequence with a duration of 2 minutes is added to the imaging protocol.
- 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. [ Time Frame: 3 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265860
|Contact: Laurence Salomon, MD PhD||0148036431 ext +firstname.lastname@example.org|
|Contact: Augustin Lecler, MDemail@example.com|
|Fondation Ophtalmologique A. de Rothschild||Recruiting|
|Contact: Augustin Lecler, MD firstname.lastname@example.org|
|Principal Investigator:||Augustin Lecler, MD||Fondation Ophtalmologique A. de Rothschild|