Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke (NCT02762552) | Clinical Trial Compass
CompletedNot Applicable
Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke
France244 participantsStarted 2015-09-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test)
Timeframe: Day 0 (inclusion)
2
Etiology of ischemic stroke according to ASCOD phenotyping (A: atherosclerosis; S: small-vessel disease; C: cardiac pathology; O: other causes D: dissection) (reference standard)