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.
Male or female, aged 18 to 85 years
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
Pregnant or breastfeeding women
Past history of stroke
Inability to follow rehabilitation procedure
Patients with ongoing treatment for SDB
Patients in the acute phase (\<72h) of a first stroke or initial/recurrent TIA, admitted in the stroke unit of the Grenoble Alpes University Hospital.
Cohort
Prospective
Treatment according to standard care recommandation
DeviceSDB treatment according to standard care recommandation: Continuous Positive Airway Pressure (CPAP), Mandibular Advancement Device, Positionnal Therapy, Adaptive Servo-Ventilation (ASV), Non-Invasive Ventilation (NIV)
Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)
Composite endpoint composed of cardiac or cerebrovascular events regrouping: death from cardiac of cerebrovascular cause, non fatal stroke (either ischemic or hemorrhagic), and non-fatal acute coronary disease
Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)
Composite endpoint composed of cardiac or cerebrovascular events regrouping: death from cardiac of cerebrovascular cause, non fatal stroke (either ischemic or hemorrhagic), and non-fatal acute coronary disease
Prevalence of secondary cardiac or cerebrovascular events
Composite endpoint composed of cardiac or cerebrovascular events regrouping: transient ischemic attack (TIA), any acute coronary disease, hospitalization for any cardio-vascular cause and peripheral artery disease
Change in BMI from inclusion to 5 years
Change in body mass index (BMI), defined as weight (Kg)/height (m)². This will be calculated at inclusion and at each visit
Change in waist, neck, and abdominal circumferences, from inclusion visit to 5 years
Change in waist, neck and abdominal circumferences in cm. This will be measured at inclusion and at each visit.
Click on the lead sponsor to view all of their trials.
