Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke (HOLISTER)
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|ClinicalTrials.gov Identifier: NCT02762552|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2016
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Transcranial-holter monitoring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||199 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup|
|Actual Study Start Date :||September 14, 2015|
|Actual Primary Completion Date :||September 14, 2017|
|Estimated Study Completion Date :||May 14, 2018|
Experimental: Transcranial-holter monitoring
Transcranial doppler in patient with ischemic stroke
Device: Transcranial-holter monitoring
Transcranial holter with an 4 hour-recording
- Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test) [ Time Frame: Day 0 (inclusion) ]Microembolic signals (MES) will be recorded using Transcranial-holter monitoring (index test) for 4 hours at the acute phase of ischemic stroke. The pattern will be described (frequency, laterality) by the observer interpreting recordings, blinded to stroke etiology as established by the reference standard.
- Etiology of ischemic stroke according to ASCOD phenotyping (A: atherosclerosis; S: small-vessel disease; C: cardiac pathology; O: other causes D: dissection) (reference standard) [ Time Frame: Month 12 ]Etiologic work-up of ischemic stroke will result in ASCOD classification (reference standard) of etiology. Work-up and classification will be established blind to the pattern of microembolic signals recordede by Transcranial-holter monitoring (index test)
- Stroke recurrence [ Time Frame: Month 12 ]Existence of a stroke recurrence will be assessed by clinical examination and possibly additional tests (imaging,..)
- Actual duration of Transcranial-holter monitoring recording [ Time Frame: Day 0 (inclusion) ]Actual duration of Transcranial-holter monitoring recording (minutes) will be measured (expected duration 4 hours) as a feasibility criterion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762552
|CHU de Bordeaux|
|Bordeaux, France, 33076|
|Principal Investigator:||Pauline Renou||University Hospital, Bordeaux|