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

Brief Summary

Detailed Description

This is a prospective cohort study that aims at comparing the proportion of incident cardiovascular events after a first stroke, first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing patients (SDB, defined as an apnea-hypopnea index \> 15 events/hour) and non-SDB patients, one year after SDB diagnosis performed by polysomnography 3 months after the cerebrovascular event. The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events (Major Adverse Cardiovascular Events, MACCEs), regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, non-fatal acute coronary event. Secondary outcomes include secondary cardiac and cerebrovascular events; stroke-related functional criteria; lesion-related criteria obtained from morphological MRI; scores on questionnaires assessing the quality of life, depression and sleep; functional, cognitive and sensorimotor evaluations; locomotion tests; and sleep-related criteria. 1620 patients, aged 18 to 85 years, in the acute phase (\<72h) of a first stroke, first or recurrent TIA, and with a score on the modified Rankin Scale (mRS) ≤1 before stroke onset, will be included in the cohort. All patients included in the study will be followed for 5 years. The schedule of follow-up will be as follow : * Selection visit (Days 0 to 3): verification of eligibility criteria, patients' or relatives' information, informed consent signature. * Inclusion visit (Days 1 to 180): clinical history and treatments, clinical evaluation and anthropometrical parameters, stroke-related criteria (including score on the National Institute of Health Stroke Scale), functional, cognitive, and sensorimotor evaluation, walking and locomotion tests, questionnaires, stroke imagery by magnetic resonance imagery, blood sampling. * SDB diagnosis (Month 3): the same clinical, MRI and biological parameters will be collected and the same questionnaires will be fulfilled by the patients. In addition, they will undergo polysomnography to assess their SDB status. Patients will be assigned to the SDB group if the AHI \> 15 events/hour; otherwise they will be assigned to the control group. Patients assigned to the SDB group will be proposed a treatment for their SDB according to standard care procedures. * Clinical follow-up: sleep and neurological; (initial 3 months and then annually after SDB diagnosis up to 5 years after SDB diagnosis): retrieval of new cardiac or cerebrovascular events (primary study outcome (MACCEs)), stroke-related parameters, questionnaires, functional, cognitive, and sensorimotor evaluations, locomotion tests, sleep follow-up (adherence to SDB treatment, tolerance, efficacy). Biological sampling will also be done at 1, 2 and 5 years after SDB diagnosis. Ancillary study - CAtSS (Carotid, Atherosclerosis, Stroke and Sleep apnea) Conjointly to the previously described ASCENT protocol, an ancillary study will be proposed to the subgroup of patients eligible for carotid surgery (endarterectomy) following their cerebrovascular event. The purpose of this ancillary study is to evaluate the impact of SDB and SDB treatment on the evolution of the carotid plaque after surgery. For the patients who accepted to participate to this ancillary study, the degree of carotid stenosis and the artery wall thickness (intima-media thickness, assessed by echo-Doppler) will be measured during the inclusion visit, at 3 months, 6 months, and at each annual visit. During surgery, a fragment of carotid plaque will be kept for morphologic and histologic analyses as well as miRNAs dosing, miARNs being recognized as indicators of carotid plaque instability. Plasmatic and urine samples will also be collected for miRNA analyses.

Primary Outcomes

Secondary Outcomes

• Change in BMI from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Clinical outcome: change Fugl-Meyer Assessment Scale from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Change in cognitive abilities from inclusion to 5 years: scores on the Montreal Cognitive Assessment Test(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Stroke characteristics : lesion volume(At inclusion)
• Plasmatic and urinary miRNAs (ancillary study)(from 3 months to 5 years after SDB diagnosis)
• Prevalence of post-operative complication (ancillary study)(from 3 months to 5 years after SDB diagnosis)
• Clinical outcome: change in modified Ranking Sale (mRS) from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Clinical outcome: change in Stroke Impact Scale (SIS-16) from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Change in walking and locomotion abilities: nFAC score, from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Assessment of sleep and fatigue: score change on Fatigue Severity Scale (FSS) from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Prevalence of respiratory disorders(3 months post-stroke)
• Concentration of C-Reactive protein(3 months)
• Change in waist, neck, and abdominal circumferences, from inclusion visit to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• ABCD² score at inclusion(at inclusion)
• Change in walking and locomotion abilities: 10m walking test, from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Change in daytime sleepiness: score on the Epworth Sleepiness Scale, from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Change in cognitive abilities from inclusion to 5 years : Language Screening Test (LAST)(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Prevalence of SDB assessed by polysomnography(3 months post-stroke)
• Change in adherence to SDB treatments, from 6 months to 5 years after SDB diagnosis(from 6 months and at each visit up to 5 years after SDB diagnosis)
• Prevalence of secondary cardiac or cerebrovascular events(5 years after SDB diagnosis)
• Change in NIHSS score from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Clinical outcome: change Patient Health Questionnaire (PHQ-9) from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Change in daytime sleepiness: score Berlin Questionnaire for Sleep Apnea (BQSA)(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Assessment of sleep and fatigue: score change on Chalder Fatigue Scale from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Assessment of sleep and fatigue: score change on Pichot's Fatigue Scale from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Change in depression symptoms from inclusion to 5 years : Pichot's Depression Scale (QD2A)(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Change in intima-media thickness (ancillary study) from 3 months to 5 years(from 3 months to 5 years after SDB diagnosis)
• Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)(5 years after SDB diagnosis)
• Clinical outcome: change in Functional Independence Measure (FIM) from inclusion to 5 years(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Change in cognitive abilities from inclusion to 5 years : scores on the Frontal Assessment Battery(at inclusion, and at each visit up to 5 years after SDB diagnosis)
• Adipose tissue analysis (ancillary study)(At baseline (carotid surgery))
• Change in degree of carotid stenosis (ancillary study)(from 3 months to 5 years after SDB diagnosis)
• miRNAs in carotid artery plaque (ancillary study)(At baseline (carotid surgery))