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Apnea, Stroke and Incident Cardiovascular Events

Recruitingn/aAges 18 Years - 85 YearsAllUniversity Hospital, Grenoble
NCT04399200 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective cohort study aims to compare the proportion of cardiac or cerebrovascular events after a first stroke, a first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing (SDB) and non-SDB (control) patients, one year after SDB diagnosis, performed 3 months after stroke onset. The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, and non-fatal acute coronary disease. 1620 patients, in the acute phase of a first stroke, TIA or recurrent TIA will be included in the cohort. Clinical, neuroimaging, sensorimotor, cognitive and biological parameters will be collected at inclusion. Three months after stroke or TIA onset, polysomnography will be performed for SDB diagnosis. Patients will be considered as having SDB for an Apnea-Hypopnea I

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female, aged 18 to 85 years * Admitted in the stroke unit no later than 72h after the onset of stroke symptoms: * First stroke confirmed by computed tomography scan or magnetic resonance imaging, whatever the localization * Initial or recurrent TIA, as defined by a brief and sudden neurological dysfunction for which an ischemic cause is presumed, with symptoms lasting less than 24 hours, and/or with no visible lesion on neuroimaging evaluation. * Score on the Modified Ranking scale (mRS) ≤1 before stroke * Signed informed consent by patient or his/her relative if not able * Patient eligible to carotid endarterectomy (for ancillary study only) Exclusion Criteria: * Pregnant or breastfeeding women * Past history of stroke * Inability to follow rehabilitation procedure * Patients with ongoing treatment for SDB * Exclusion period for another study * Patients not affiliated to a French social and health insurance system or equivalent * Prisoners or patients who require protection by the law
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What it tests

  • Treatment according to standard care recommandation
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Where

1 site
University Hospital Grenoble
Grenoble, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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