RecruitingNCT04399200

Apnea, Stroke and Incident Cardiovascular Events

Sleep Apnea Syndrome and Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) After a First Stroke


Sponsor

University Hospital, Grenoble

Enrollment

1,620 participants

Start Date

Jul 13, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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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Interventions

DEVICETreatment according to standard care recommandation

SDB treatment according to standard care recommandation: Continuous Positive Airway Pressure (CPAP), Mandibular Advancement Device, Positionnal Therapy, Adaptive Servo-Ventilation (ASV), Non-Invasive Ventilation (NIV)


Locations(1)

University Hospital Grenoble

Grenoble, France

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NCT04399200


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