Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke "HOLISTER"

Active, not recruiting

Phase N/A Results N/A

Trial Description

In acute ischemic stroke, the identification of an etiology is of major importance to prevent recurrence by providing the best treatment. Because of numerous possible underlying etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic tests, which can be invasive, long and expensive. Moreover, many patients receive a diagnosis of undetermined stroke even after all available diagnosis tests are done, precluding optimal treatment.

Detailed Description

Asymptomatic MES detected by transcranial doppler have been reported in patient with ischemic stroke. It has been previously demonstrated that MES predict stroke recurrence and that the frequency of MES depends on stroke etiology. However, the pattern of MES has never been correlated to stroke etiology. Transcranial-holter is a novel ambulatory system which allows prolonged recording (up to 4 hours) leading to an increased detection of MES.
Therefore, transcranial holter with an 4 hour-recording will be performed for consecutive eligible patients hospitalized in our stroke care unit. During the recording, the patient will be able to continue their usual activities (eating, walking, speaking and sleeping).
All the included patients will have a classical follow-up at 3, 6 months and 12 months. The neurologist, blinded to the results of transcranial-holter, will have to prescribe and analyze the results of diagnostic tests to identify stroke etiology. Stroke etiology will be established according to the ASCOD classification. Questioning and neurological exam (NIHSS score) will be performed looking for potential recurrent stroke.

Conditions

Interventions

  • Transcranial-holter monitoring Device
    Intervention Desc: Transcranial holter with an 4 hour-recording
    ARM 1: Kind: Experimental
    Label: Transcranial-holter monitoring
    Description: Transcranial doppler in patient with ischemic stroke

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test) Day 0 (inclusion) No
Primary Etiology of ischemic stroke according to ASCOD phenotyping (A: atherosclerosis; S: small-vessel disease; C: cardiac pathology; O: other causes D: dissection) (reference standard) Month 6 No
Secondary Stroke recurrence Month 6 No
Secondary Actual duration of Transcranial-holter monitoring recording Day 0 (inclusion) No

Sponsors