Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors

Study Overview
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Brief Summary
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The AMISLEEP study is nested in the FRENCHIE registry. The objective is to use routine clinical and polygraphic data to capture SDB/SAS (Sleep Disordered Breathing/Sleep Apnea Syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes. Specifically, the investigators hypothesize that unique clusters (phenotypes) of patients could be identified by applying unsupervised learning methods to these data and that the clusters would be differentially associated with risk of adverse cardiovascular outcomes (ACS), TIA, stroke or death). The ultimate goal is to identify patients more at risk that could be included in interventional studies that would test whether SDB/SAS treatment can improve this risk.

Detailed Description
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All patients included in the FRENCHIE registry (Acute Myocardial Infarction (AMI) patients hospitalized within 48h from symptom onset) are eligible, and will be asked for their written informed consent for this nested study in case of the absence of any non-inclusion criteria. Baseline clinical examination and laboratory tests are based on the usual care and are those collected in FRENCHIE. A simplified polygraphy is performed during the hospitalization for AMI. Starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours. Together with the polygraphy, questionnaires will be given to the patient regarding general sleep quality Polygraphic data will be scored in centralized manner. Results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up. If necessary, the core-lab will provide tele-counseling regarding SDB management to centers. Follow-up will be performed through the national administrative databases, as in the FRENCHIE registry.

Official Title
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SDB Prevalence and Cardiovascular Outcomes of MI Survivors

Conditions
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Acute Myocardial Infarction, Sleep Apnea

Intervention / Treatment
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* Diagnostic Test: Polygraphy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient included in FRENCHIE registry (cf. NCT04050956 for FRENCHIE registry's selection criteria) Signed consent for AMI-Sleep study Exclusion Criteria: Patient under treatment for SDB/SAS prior to its inclusion in FRENCHIE registry Cognitive disorientation and communicative disabilities (left to investigator's discretion) not able to fill-out a questionnaire Severe diseases with anticipated mortality less than 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polygraphy<br> | Diagnostic Test: Polygraphy<br>* The polygraphy consists of recording during sleep, respiratory flow by mean of a nasal cannula, respiratory movement by mean of a thoracic belt with inductance plethysmography, blood oxygenation and heartbeats by a fingertip transcutaneous oxymetry. Starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours. Polygraphy data are anonymized before being sent to the Cloud and therefore to the core lab. Polygraphic data will be scored in centralized manner. Results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up. If necessary, the core-lab will provide tele-counseling regarding SDB management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contribution of SDB/SAS to events after AMI | Contribution of SDB/SAS to incident cardiovascular events and mortality during the first year following acute myocardial infraction : Cardiovascular event will be defined as incident acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke or death of any cause after discharge during the first year following the AMI event. Time from discharge to the first event will be considered. | 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations between presence, type and severity of SDB and the severity of the initial coronary disease | The severity of the index event (number of stents combined with revascularizations and coronary bypass) will be compared to type and severity of SDB (apnea-hypopnea index AHI), to evaluate if both are associated | Through the end of hospitalization, an average of 5 days | 
| Validate the Berlin questionnaire to screen for obstructive and central SDB/SAS in the AMI patients | Concordance between the result of the Berlin questionnaire and the presence of obstructive SDB/SAS measured by polygraphy as reference and concordance between the result of the Berlin questionnaire and the presence of central SDB/SAS measured by polygraphy as reference. | Through the end of hospitalization, an average of 5 days | 
| Evaluate health care related costs during the year following hospital discharge. | Health care related costs for SDB considered will be: confirmation of SDB by an additional polysomnography, SDB treatments. | 12 months follow up | 
| Comparison of health care consumption between SDB and non-SDB patients | Health care consumption and health care related costs will be compared between patients : without SDB with mild SDB (AHI between 5 and 14/h) with moderate SDB (AHI between 15h to 29/h) with severe SDB (AHI ≥ 30/h) Health care consumption and health care related costs considered will be AMI recurrence, incident TIA/stroke, cardiac arrhythmia, heart decompensation, diabetes, depression and cancers. | 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myocardial Infarction, Sleep Apnea, Outcomes