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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04108754
Other study ID # TIA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date December 1, 2018

Study information

Verified date September 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 376
Est. completion date December 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

-

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Hospices Civils de Lyon Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 90 days
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