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

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ClinicalTrials.gov Identifier: NCT03928977
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

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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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

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): NCT03928977


Contacts
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Contact: Louise BONNET, MD 033381668984 l1bonnet@chu-besancon.fr
Contact: Guillaume CHARBONNIER, Int gcharbonnier@ymail.com

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03928977     History of Changes
Other Study ID Numbers: P/2018/370
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Transient Ischemic Attack
Stroke
functional Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Ischemic Attack, Transient
Ischemia
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases