NCT03265860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2021

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3.6 years

First QC Date

August 28, 2017

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with an acute ischemic stroke

You may qualify if:

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

You may not qualify if:

  • Absolute contraindications to MRI
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, France

Location

Related Publications (1)

  • Sajust de Bergues de Escalup A, Duron L, Seners P, Sabben C, Obadia M, Yavchitz A, Savatovsky J, Lecler A. Prediction of functional outcome in patients with ischemic stroke using advanced diffusion-weighted MRI parameters at 3 Tesla. Diagn Interv Imaging. 2026 Mar 19:S2211-5684(26)00049-5. doi: 10.1016/j.diii.2026.03.001. Online ahead of print.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Augustin Lecler, MD

    Fondation Ophtalmologique A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 29, 2017

Study Start

August 10, 2017

Primary Completion

March 14, 2021

Study Completion

June 14, 2021

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations