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出境医 / 临床实验 / Functional Imaging in the Acute Phase of Transient Ischemic Attacks (IMAGE AIT)

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

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.

Condition or disease Intervention/treatment Phase
Transient Ischemic Attack Diagnostic Test: Functional Magnetic Resonance Imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021
Arms and Interventions
Arm Intervention/treatment
Confirmed TIA
Confirmed TIA at 3 months with standardized neurological expertise
 Diagnostic Test: Functional Magnetic Resonance Imaging
fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition
Confirmed non-TIA
Not-confirmed TIA at 3 months with standardized neurological expertise
 Diagnostic Test: Functional Magnetic Resonance Imaging
fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition
Outcome Measures
Primary Outcome Measures :
  1. Blood-Oxygen-Level Dependent signal [ Time Frame: 24 hours after symptoms onset ]
    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 :
  1. Resting state [ Time Frame: 24 hours after symptoms onset ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Louise BONNET, MD 033381668984 l1bonnet@chu-besancon.fr
Contact: Guillaume CHARBONNIER, MD g1charbonnier@chu-besancon.fr

Locations
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France
CHU de Besançon Recruiting
Besançon, France, 25030
Contact: Guillaume Charbonnier, MD       g1charbonnier@chu-besancon.fr   
Principal Investigator: Louise Bonnet, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE October 15, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		Blood-Oxygen-Level Dependent signal [ Time Frame: 24 hours after symptoms onset ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		Resting state [ Time Frame: 24 hours after symptoms onset ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Imaging in the Acute Phase of Transient Ischemic Attacks
Official Title  ICMJE Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Transient Ischemic Attack
Intervention  ICMJE Diagnostic Test: Functional Magnetic Resonance Imaging
fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition
Study Arms  ICMJE
  • Confirmed TIA
    Confirmed TIA at 3 months with standardized neurological expertise
    Intervention: Diagnostic Test: Functional Magnetic Resonance Imaging
  • Confirmed non-TIA
    Not-confirmed TIA at 3 months with standardized neurological expertise
    Intervention: Diagnostic Test: Functional Magnetic Resonance Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019) 		70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Louise BONNET, MD 033381668984 l1bonnet@chu-besancon.fr
Contact: Guillaume CHARBONNIER, MD g1charbonnier@chu-besancon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928977
Other Study ID Numbers  ICMJE P/2018/370
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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