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Functional Imaging in the Acute Phase of Transient Ischemic Attacks (IMAGE AIT)

Primary Purpose

Transient Ischemic Attack

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Magnetic Resonance Imaging
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transient Ischemic Attack focused on measuring Transient Ischemic Attack, Stroke, functional Magnetic Resonance Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient admitted in for a transient neurologic deficit and suspicion of TIA of carotid circulation
  • Prescription for conventionnal MRI

Exclusion Criteria:

  • Contraindication to MRI
  • Previous neurological disease (with lesions)
  • Severe psychiatric disease

Sites / Locations

  • CHU de BesançonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Confirmed TIA

Confirmed non-TIA

Arm Description

Confirmed TIA at 3 months with standardized neurological expertise

Not-confirmed TIA at 3 months with standardized neurological expertise

Outcomes

Primary Outcome Measures

Blood-Oxygen-Level Dependent signal
BOLD effect differences in motor cortex from pathological side versus healthy side measured by fMRI within the 24 hours after symptom onset, during a motor paradigm

Secondary Outcome Measures

Resting state
Bold effect differences in resting state networks from pathological side versus healthy side measured by fMRI within the 24 hours after symptom onset, during a motor paradigm

Full Information

First Posted
April 24, 2019
Last Updated
November 18, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03928977
Brief Title
Functional Imaging in the Acute Phase of Transient Ischemic Attacks
Acronym
IMAGE AIT
Official Title
Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to find a radiological biomarker of Transient Ischemic Attacks (TIA) thanks to functional Magnetic Resonance Imaging (fMRI) done within the 24 hour after symptoms onset.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack
Keywords
Transient Ischemic Attack, Stroke, functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Confirmed TIA
Arm Type
Other
Arm Description
Confirmed TIA at 3 months with standardized neurological expertise
Arm Title
Confirmed non-TIA
Arm Type
Other
Arm Description
Not-confirmed TIA at 3 months with standardized neurological expertise
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional Magnetic Resonance Imaging
Intervention Description
fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition
Primary Outcome Measure Information:
Title
Blood-Oxygen-Level Dependent signal
Description
BOLD effect differences in motor cortex from pathological side versus healthy side measured by fMRI within the 24 hours after symptom onset, during a motor paradigm
Time Frame
24 hours after symptoms onset
Secondary Outcome Measure Information:
Title
Resting state
Description
Bold effect differences in resting state networks from pathological side versus healthy side measured by fMRI within the 24 hours after symptom onset, during a motor paradigm
Time Frame
24 hours after symptoms onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient admitted in for a transient neurologic deficit and suspicion of TIA of carotid circulation Prescription for conventionnal MRI Exclusion Criteria: Contraindication to MRI Previous neurological disease (with lesions) Severe psychiatric disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louise BONNET, MD
Phone
033381668984
Email
l1bonnet@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume CHARBONNIER, MD
Email
g1charbonnier@chu-besancon.fr
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Charbonnier, MD
Email
g1charbonnier@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Louise Bonnet, MD

12. IPD Sharing Statement

Learn more about this trial

Functional Imaging in the Acute Phase of Transient Ischemic Attacks

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