Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke (HOLISTER)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial-holter monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke focused on measuring Stroke, Etiology, Recurrence, Transcranial holter, Microembolic signals
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcranial-holter monitoring
Arm Description
Transcranial doppler in patient with ischemic stroke
Outcomes
Primary Outcome Measures
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.
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)
Secondary Outcome Measures
Stroke recurrence
Existence of a stroke recurrence will be assessed by clinical examination and possibly additional tests (imaging,..)
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
Full Information
NCT ID
NCT02762552
First Posted
August 7, 2015
Last Updated
February 22, 2019
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT02762552
Brief Title
Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke
Acronym
HOLISTER
Official Title
Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 14, 2015 (Actual)
Primary Completion Date
May 11, 2017 (Actual)
Study Completion Date
August 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Etiology, Recurrence, Transcranial holter, Microembolic signals
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial-holter monitoring
Arm Type
Experimental
Arm Description
Transcranial doppler in patient with ischemic stroke
Intervention Type
Device
Intervention Name(s)
Transcranial-holter monitoring
Intervention Description
Transcranial holter with an 4 hour-recording
Primary Outcome Measure Information:
Title
Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test)
Description
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.
Time Frame
Day 0 (inclusion)
Title
Etiology of ischemic stroke according to ASCOD phenotyping (A: atherosclerosis; S: small-vessel disease; C: cardiac pathology; O: other causes D: dissection) (reference standard)
Description
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)
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Stroke recurrence
Description
Existence of a stroke recurrence will be assessed by clinical examination and possibly additional tests (imaging,..)
Time Frame
Month 12
Title
Actual duration of Transcranial-holter monitoring recording
Description
Actual duration of Transcranial-holter monitoring recording (minutes) will be measured (expected duration 4 hours) as a feasibility criterion
Time Frame
Day 0 (inclusion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Renou
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
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Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke
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