NCT04399200 Apnea, Stroke and Incident Cardiovascular Events
| NCT ID | NCT04399200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,620 participants |
| Start Date | 2020-07-13 |
| Primary Completion | 2030-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,620 participants in total. It began in 2020-07-13 with a primary completion date of 2030-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Index (AHI) \> 15 events/hour, or to the control group otherwise. The same clinical, imaging, cognitive and biological assessments than during the first visit will be performed; incident (new) cardiovascular events will be collected. Three months later, and at 1, 2, 3, 4 and 5 years after SDB diagnosis, the same clinical, cognitive, sensorimotor, and sleep-related evaluations will be performed. In addition to the aforementioned parameters, incident cardiovascular outcomes will be collected, at the same time points. The primary study outcome will be retrieved one year after stroke onset.
Eligibility Criteria
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
Contact & Investigator
Renaud Tamisier, MD, PhD, MBA
PRINCIPAL INVESTIGATOR
University Hospital, Grenoble
Frequently Asked Questions
Who can join the NCT04399200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04399200 currently recruiting?
Yes, NCT04399200 is actively recruiting participants. Contact the research team at sbaillieul@chu-grenoble.fr for enrollment information.
Where is the NCT04399200 trial being conducted?
This trial is being conducted at Grenoble, France.
Who is sponsoring the NCT04399200 clinical trial?
NCT04399200 is sponsored by University Hospital, Grenoble. The principal investigator is Renaud Tamisier, MD, PhD, MBA at University Hospital, Grenoble. The trial plans to enroll 1,620 participants.
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