NCT03928977

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

April 24, 2019

Last Update Submit

November 18, 2019

Conditions

Transient Ischemic Attack

Keywords

Transient Ischemic AttackStrokefunctional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours after symptoms onset

Secondary Outcomes (1)

  • Resting state

    24 hours after symptoms onset

Study Arms (2)

Confirmed TIA

OTHER

Confirmed TIA at 3 months with standardized neurological expertise

Diagnostic Test: Functional Magnetic Resonance Imaging

Confirmed non-TIA

OTHER

Not-confirmed TIA at 3 months with standardized neurological expertise

Diagnostic Test: Functional Magnetic Resonance Imaging

Interventions

Functional Magnetic Resonance ImagingDIAGNOSTIC_TEST

fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition

Confirmed TIAConfirmed non-TIA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25030, France

RECRUITING

MeSH Terms

Conditions

Ischemic Attack, TransientStroke

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Louise BONNET, MD

CONTACT

033381668984l1bonnet@chu-besancon.fr

Guillaume CHARBONNIER, MD

CONTACT

g1charbonnier@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

October 15, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

FR(1)