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

Stroke Clinical Trial

— HOLISTER  

Official title:

Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762552
• Other study ID #: CHUBX 2014/14
• Status: Completed
• Phase: N/A
• Start date: September 14, 2015
• Est. completion date: August 14, 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: August 14, 2018
• Est. primary completion date: May 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcranial-holter monitoring
Transcranial holter with an 4 hour-recording

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test)	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.	Day 0 (inclusion)
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)	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)	Month 12
Secondary	Stroke recurrence	Existence of a stroke recurrence will be assessed by clinical examination and possibly additional tests (imaging,..)	Month 12
Secondary	Actual duration of Transcranial-holter monitoring recording	Actual duration of Transcranial-holter monitoring recording (minutes) will be measured (expected duration 4 hours) as a feasibility criterion	Day 0 (inclusion)