Clinical trial NCT02762552: Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke
Official title: Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Etiology
Recurrence
Transcranial holter
Microembolic signals
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke in the middle cerebral artery territory
* Acute ischemic stroke within the 7 first days from the onset of the symptoms
* Patient hospitalized in our stroke care unit
* Man or woman older than 18 years
* Patient affiliated to a social security system
* Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)

Exclusion Criteria:

* Transient ischemic stroke
* Ischemic stroke in the vertebro-basilar or anterior cerebral artery territory.
* Proximal middle cerebral artery occlusion leading to the impossibility of recording
* Patient who could not express his consent
* Patient under guardianship or judicial protection
* Pregnant or breastfeeding woman
* Emergency situation
* Life expectancy under 6 months

Exclusion criteria (after inclusion) :

* Absent of bilateral Acoustic window
* Analyzable Recording \<30min

Primary outcomes:
measure: Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test)
timeFrame: Day 0 (inclusion)
measure: Etiology of ischemic stroke according to ASCOD phenotyping (A: atherosclerosis; S: small-vessel disease; C: cardiac pathology; O: other causes D: dissection) (reference standard)
timeFrame: Month 12
Secondary outcomes:
measure: Stroke recurrence
timeFrame: Month 12
measure: Actual duration of Transcranial-holter monitoring recording
timeFrame: Day 0 (inclusion)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Pauline Renou
role: PRINCIPAL_INVESTIGATOR
References: