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CompletedNCT04108754TIAUpdated Sep 30, 2019

Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack

An observational study in Diagnosis of TIA and MRI, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
376
Ages
18 Years and older
Sex
All
01

Study summary

Predicting the risk of stroke remains a challenge in the management of transient ischemic attack (TIA). In addition to clinical variables, morphological features such as the presence of a diffusion weighted sequence (DWI) lesion and carotid stenosis of at least 50% improve risk stratification and are considered in the literature. score ABCD3-I1. Several studies have shown that brain microhemorrhages are associated with the risk of early stroke in patients with TIA. Data on white matter hypersignals on the T2-weighted sequence or FLAIR (FLuid Attenuated Inversion Recovery) are more conflicting. The global microangiopathic load, including the gaps, the hypersignals of the white matter, the perivascular spaces visible on MRI in the basal ganglia, especially when they are very numerous (> 20) and the gaps, have recently been described as being associated with stroke risk within 2 to 3 years of TIA or ischemic stroke. To date, the predictive value of global microangiopathic burden on early stroke risk in the course of TIA is not known.

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Conditions studied

  • Diagnosis of TIA
  • MRI
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In context

Ischemic Attack, Transient

293 studies on the registry are indexed under Ischemic Attack, Transient; 64 are open to participants now.

This study's enrollment of 376 is above the median of 333 across 120 observational studies indexed under Ischemic Attack, Transient.

Browse Ischemic Attack, Transient studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients in the neurovascular unit of the Neurological Hospital of Lyon between 01/01/2016 and 30/12/2017 with a probable diagnosis of TIA and having an MRI within 7 days of the TIA.

Inclusion criteria

  • Patients with probable TIA with Regression of symptoms within 24 hours (unilateral motor or sensory disorders affecting the face and / or limbs , language disorder, blindness of an eye or amputation of a visual field)
  • Patients with possible AIT with 2 of these symptoms associated: fear of heights, diplopia, dysarthria, disorders of swallowing, loss of balance, isolated sensory symptoms affecting only part of a limb or hemiface.
  • Patient who have had a brain MRI.
  • Patient over 18 year-old.
  • Patient who give their non opposition to participate at the study.

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
376 participants (actual)
Patient registry
No

Groups and cohorts

  • Diagnosis of AIT

    Patients in the neurovascular unit of the Neurological Hospital of Lyon between 01/01/2016 and 30/12/2017 with a probable diagnosis of AIT and having an MRI within 7 days of TIA.

    Other: microangiopathic burden

Interventions

  • Othermicroangiopathic burden

    to determine the value of the global microangiopathic burden on the prediction of early stroke risk in a homogeneous cohort of TIA.

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What researchers measure

Primary outcomes

  1. stroke recurrence within 90 days,

    The stroke recurrence within 90 days is determined via a clinical consultation or telephone call to the patient with a structured questionnaire.

    Time frame: 90 days

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Study locations

1 site
  • Hospices Civils de Lyon
    Bron, 69677, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04108754
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Sep 30, 2019
Start date
Aug 1, 2018
Primary completion
Aug 1, 2018
Completion
Dec 1, 2018
Last update
Sep 30, 2019

Study contacts

Norbert NIGHOGHOSSIAN
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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