We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified August 2017 by Fondation Ophtalmologique Adolphe de Rothschild
Sponsor:
ClinicalTrials.gov Identifier:
NCT03265860
First Posted: August 29, 2017
Last Update Posted: August 30, 2017
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.
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild
  Purpose

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 Intervention
Stroke Magnetic Resonance Imaging Device: IntraVoxel Incoherent Motion sequence

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Fondation Ophtalmologique Adolphe de Rothschild:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 250
Actual Study Start Date: August 14, 2017
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: IntraVoxel Incoherent Motion sequence
    The IVIM diffusion sequence with a duration of 2 minutes is added to the imaging protocol.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an acute ischemic stroke
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Laurence Salomon, MD PhD 0148036431 ext +33 lsalomon@for.paris
Contact: Augustin Lecler, MD alecler@for.paris

Locations
France
Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France
Contact: Augustin Lecler, MD       alecler@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Augustin Lecler, MD Fondation Ophtalmologique A. de Rothschild
  More Information

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03265860     History of Changes
Other Study ID Numbers: ALR_2017_5
First Submitted: August 28, 2017
First Posted: August 29, 2017
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases