Actively Recruiting
Apnea, Stroke and Incident Cardiovascular Events
Led by University Hospital, Grenoble · Updated on 2025-02-11
1620
Participants Needed
1
Research Sites
776 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Apnea, Stroke and Incident Cardiovascular Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to 85 years
- Admitted to the stroke unit within 72 hours after onset of stroke symptoms
- First stroke confirmed by CT scan or MRI, any location
- Initial or recurrent TIA defined by brief sudden neurological dysfunction with symptoms lasting less than 24 hours and/or no visible lesion on imaging
- Modified Rankin Scale score of 1 or less before stroke
- Signed informed consent by patient or relative if patient unable
- Eligible for carotid endarterectomy (for ancillary study only)
You will not qualify if you...
- Pregnant or breastfeeding women
- History of previous stroke
- Inability to follow rehabilitation procedures
- Currently receiving treatment for sleep-disordered breathing
- Participation in exclusion period for another study
- Not affiliated with French social and health insurance or equivalent
- Prisoners or individuals under legal protection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Grenoble
Grenoble, France, 38043
Actively Recruiting
Research Team
S
Sébastien Baillieul, MD, MSc
CONTACT
S
Sara Saadi, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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