StrokeHOLISTERNCT02762552
Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke
A study testing Transcranial-holter monitoring in people with Stroke, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial-holter monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2015to 14 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- Emergency situation
- Life expectancy under 6 months
- Absent of bilateral Acoustic window
- Analyzable Recording <30min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup
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.
Read the 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
- Stroke
- Being tested
- Transcranial-holter monitoring
- Keywords
- Stroke, Etiology, Recurrence, Transcranial holter, Microembolic signals
- Medical subject headings
- Stroke, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial-holter monitoringDevice
Transcranial holter with an 4 hour-recording
| Study group | Role | What they receive |
|---|---|---|
| Transcranial-holter monitoring | Experimental | Transcranial doppler in patient with ischemic stroke Receives: Device: Transcranial-holter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (inclusion)
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)
Measured: Month 12
Secondary outcomes (2)
Stroke recurrence
Existence of a stroke recurrence will be assessed by clinical examination and possibly additional tests (imaging,..)
Measured: Month 12
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
Measured: Day 0 (inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start14 Sep 2015
- Primary completion11 May 2017
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Renou, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762552
- Sponsor's protocol ID
- CHUBX 2014/14
- Other IDs
- 2014-A01951-46
- Acronym
- HOLISTER
- Status last verified
- Feb 2019
- First submitted
- 7 Aug 2015
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup
- ClinicalTrials.gov ID
- NCT02762552
- Acronym / sponsor ID
- HOLISTER / CHUBX 2014/14
- Conditions
- Stroke
- Keywords
- Stroke, Etiology, Recurrence, Transcranial holter, Microembolic signals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 14 Sep 2015 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial-holter monitoring | Experimental | Device: Transcranial-holter monitoringTranscranial doppler in patient with ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial-holter monitoringTranscranial holter with an 4 hour-recording | Device | Transcranial-holter monitoring |
Primary outcome
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)
2 secondary outcomes
Stroke recurrence
Time frame: Month 12
Actual duration of Transcranial-holter monitoring recording
Time frame: Day 0 (inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline Renou principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial-holter monitoring in people with Stroke, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test) (time frame: Day 0 (inclusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.