Clinical trial NCT04399200: Apnea, Stroke and Incident Cardiovascular Events
Official title: Sleep Apnea Syndrome and Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) After a First Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Sleep-disordered Breathing
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Fragmentation, Sleep
Keywords: Stroke
Sleep-disordered Breathing
Cardio-Vascular Events
Atherosclerosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 1620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

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

Primary outcomes:
measure: Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)
timeFrame: 1 year after SDB diagnosis
Secondary outcomes:
measure: Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)
timeFrame: 5 years after SDB diagnosis
measure: Prevalence of secondary cardiac or cerebrovascular events
timeFrame: 5 years after SDB diagnosis
measure: Change in BMI from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in waist, neck, and abdominal circumferences, from inclusion visit to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in NIHSS score from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: ABCD² score at inclusion
timeFrame: at inclusion
measure: Clinical outcome: change in modified Ranking Sale (mRS) from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Clinical outcome: change in Functional Independence Measure (FIM) from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Clinical outcome: change in Stroke Impact Scale (SIS-16) from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Clinical outcome: change Patient Health Questionnaire (PHQ-9) from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Clinical outcome: change Fugl-Meyer Assessment Scale from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in walking and locomotion abilities: nFAC score, from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in walking and locomotion abilities: 10m walking test, from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in daytime sleepiness: score on the Epworth Sleepiness Scale, from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in daytime sleepiness: score Berlin Questionnaire for Sleep Apnea (BQSA)
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Assessment of sleep and fatigue: score change on Chalder Fatigue Scale from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Assessment of sleep and fatigue: score change on Fatigue Severity Scale (FSS) from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Assessment of sleep and fatigue: score change on Pichot's Fatigue Scale from inclusion to 5 years
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in depression symptoms from inclusion to 5 years : Pichot's Depression Scale (QD2A)
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in cognitive abilities from inclusion to 5 years: scores on the Montreal Cognitive Assessment Test
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in cognitive abilities from inclusion to 5 years : scores on the Frontal Assessment Battery
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Change in cognitive abilities from inclusion to 5 years : Language Screening Test (LAST)
timeFrame: at inclusion, and at each visit up to 5 years after SDB diagnosis
measure: Prevalence of SDB assessed by polysomnography
timeFrame: 3 months post-stroke
measure: Prevalence of respiratory disorders
timeFrame: 3 months post-stroke
measure: Change in adherence to SDB treatments, from 6 months to 5 years after SDB diagnosis
timeFrame: from 6 months and at each visit up to 5 years after SDB diagnosis
measure: Stroke characteristics : lesion volume
timeFrame: At inclusion
measure: Concentration of C-Reactive protein
timeFrame: 3 months
measure: Change in degree of carotid stenosis (ancillary study)
timeFrame: from 3 months to 5 years after SDB diagnosis
measure: Change in intima-media thickness (ancillary study) from 3 months to 5 years
timeFrame: from 3 months to 5 years after SDB diagnosis
measure: Plasmatic and urinary miRNAs (ancillary study)
timeFrame: from 3 months to 5 years after SDB diagnosis
measure: miRNAs in carotid artery plaque (ancillary study)
timeFrame: At baseline (carotid surgery)
measure: Prevalence of post-operative complication (ancillary study)
timeFrame: from 3 months to 5 years after SDB diagnosis
measure: Adipose tissue analysis (ancillary study)
timeFrame: At baseline (carotid surgery)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Renaud Tamisier, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
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