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Multimodal MRI Study of Ischemic Stroke

Primary Purpose

STROKE

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MULTIMODAL MRI
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for STROKE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Patient having presented a cerebral infarct beforehand confirmed by the brain imaging

  • Patient having presented a cerebral infarct the hour of the beginning of which is known with certainty and dating less than 24 hours
  • Patient having presented a cerebral infarct the area(extent) of which is superior to 1,5 ml

Exclusion Criteria:

  • Patients presenting the usual contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
  • Patients presenting a risk of not compliance to the examination: disorders(confusions) of the elementary understanding, the confusion, the involuntary movements, the bad tolerance of the prolonged dorsal decubitus

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

multimodal MRI

multimocal MRI

Arm Description

Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months for patients whom suffering stroke

Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months for healthy subjects

Outcomes

Primary Outcome Measures

The time of stroke onset
The main objective of the present study is to test the accuracy of sodium MRI to determine the time of stroke onset

Secondary Outcome Measures

The degree of tissue damage and brain reorganization after stroke
The secondary objectives of the study are to determine the ability of non-conventional MRI techniques to quantify the degree of tissue damage and brain reorganization after stroke.

Full Information

First Posted
February 16, 2015
Last Updated
August 23, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02369328
Brief Title
Multimodal MRI Study of Ischemic Stroke
Official Title
Multimodal MRI Study of Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is the second most frequent causes of mortality in the word after cardiovascular disease and the most frequent cause of disability. The majority of strokes are ischemic (87%). Ischemic stroke may benefit from efficient therapy if the delay from stroke onset not exceeds 4H30 (intra-venous thrombolysis). In case of irreversible cerebral lesion, the long term functional recovery is largely dependent from the ability of the brain to reorganize. Conventional magnetic resonance imaging represents the most sensitive tool to diagnose stroke at the acute phase. However, up to now, no imaging tool is available to determine the time of stroke onset. Moreover, no imaging tool is available to precisely quantify the functional and structural plasticity mechanisms occurring after stroke. The main objective of the present study is to test the accuracy of sodium MRI to determine the time of stroke onset. The secondary objectives of the study are to determine the ability of non-conventional MRI techniques to quantify the degree of tissue damage and brain reorganization after stroke. Thirty patients will be included during the first 24 hours after stroke onset. Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STROKE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multimodal MRI
Arm Type
Experimental
Arm Description
Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months for patients whom suffering stroke
Arm Title
multimocal MRI
Arm Type
Active Comparator
Arm Description
Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months for healthy subjects
Intervention Type
Device
Intervention Name(s)
MULTIMODAL MRI
Intervention Description
Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months and neurological clinical exam , rankin score, NIHSS
Primary Outcome Measure Information:
Title
The time of stroke onset
Description
The main objective of the present study is to test the accuracy of sodium MRI to determine the time of stroke onset
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The degree of tissue damage and brain reorganization after stroke
Description
The secondary objectives of the study are to determine the ability of non-conventional MRI techniques to quantify the degree of tissue damage and brain reorganization after stroke.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Patient having presented a cerebral infarct beforehand confirmed by the brain imaging Patient having presented a cerebral infarct the hour of the beginning of which is known with certainty and dating less than 24 hours Patient having presented a cerebral infarct the area(extent) of which is superior to 1,5 ml Exclusion Criteria: Patients presenting the usual contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.) Patients presenting a risk of not compliance to the examination: disorders(confusions) of the elementary understanding, the confusion, the involuntary movements, the bad tolerance of the prolonged dorsal decubitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BERTRAND AUDOUIN, MD
Email
b.audoin@ap-hm.fr
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Multimodal MRI Study of Ischemic Stroke

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