Transient Ischemic AttackIMAGE AITNCT03928977
Functional Imaging in the Acute Phase of Transient Ischemic Attacks
A study testing Functional Magnetic Resonance Imaging in people with Transient Ischemic Attack, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack
- What is being tested?
- Functional Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2019to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted in for a transient neurologic deficit and suspicion of TIA of carotid circulation
- Prescription for conventionnal MRI
Who cannot join
- Contraindication to MRI
- Previous neurological disease (with lesions)
- Severe psychiatric disease
Trial locations and contacts
1 site in 1 country.
Guillaume CHARBONNIER, MD contact
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25030
Guillaume Charbonnier, MD, g1charbonnier@chu-besancon.fr
Louise Bonnet, MD
About this study
Official title: Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study
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.
- Conditions
- Transient Ischemic Attack
- Being tested
- Functional Magnetic Resonance Imaging
- Keywords
- Transient Ischemic Attack, Stroke, functional Magnetic Resonance Imaging
- Medical subject headings
- Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance ImagingDiagnostic test
fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition
| Study group | Role | What they receive |
|---|---|---|
| Confirmed TIA | Other | Confirmed TIA at 3 months with standardized neurological expertise Receives: Diagnostic Test: Functional Magnetic Resonance Imaging |
| Confirmed non-TIA | Other | Not-confirmed TIA at 3 months with standardized neurological expertise Receives: Diagnostic Test: Functional Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours after symptoms onset
Secondary outcomes (1)
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
Measured: 24 hours after symptoms onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start15 Oct 2019
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928977
- Sponsor's protocol ID
- P/2018/370
- Acronym
- IMAGE AIT
- Status last verified
- Nov 2019
- First submitted
- 24 Apr 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study
- ClinicalTrials.gov ID
- NCT03928977
- Acronym / sponsor ID
- IMAGE AIT / P/2018/370
- Conditions
- Transient Ischemic Attack
- Keywords
- Transient Ischemic Attack, Stroke, functional Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed TIA | Other | Diagnostic Test: Functional Magnetic Resonance ImagingConfirmed TIA at 3 months with standardized neurological expertise |
| Confirmed non-TIA | Other | Diagnostic Test: Functional Magnetic Resonance ImagingNot-confirmed TIA at 3 months with standardized neurological expertise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient admitted in for a transient neurologic deficit and suspicion of TIA of carotid circulation
- Prescription for conventionnal MRI
Key exclusion criteria (3 listed)
- Contraindication to MRI
- Previous neurological disease (with lesions)
- Severe psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic Resonance ImagingfMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition | Diagnostic test | Confirmed TIA, Confirmed non-TIA |
Primary outcome
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
1 secondary outcome
Resting state
Time frame: 24 hours after symptoms onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume CHARBONNIER, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Resonance Imaging in people with Transient Ischemic Attack, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise BONNET, MD (033381668984, l1bonnet@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-Oxygen-Level Dependent signal (time frame: 24 hours after symptoms onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.