ArticleBMJ open2025
AMI-Sleep: protocol for a prospective study of sleep-disordered breathing/sleep apnoea syndrome and incident cardiovascular events after acute myocardial infarction.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04064593 (SDB Prevalence and Cardiovascular Outcomes of MI Survivors), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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SDB Prevalence and Cardiovascular Outcomes of MI Survivors
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10 authors.
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Abstract
introductionSleep-disordered breathing (SDB) and the related clinical syndrome, sleep apnoea syndrome (SAS), are highly prevalent in patients with ischaemic heart disease and often remain undiagnosed. The AMI-Sleep study will describe its prevalence in patients with acute myocardial infarction (AMI) and assess the independent contribution of the type and severity of SDB/SAS to subsequent incident cardiovascular events and mortality. METHODS AND ANALYSIS: This prospective study will include patients hospitalised for AMI enrolled in the multicentre nationwide prospective French Cohort of Myocardial Infarction Evaluation (FRENCHIE) registry. A nightly simplified polygraphy is performed before discharge from the index AMI admission, and participants complete two self-administered sleep questionnaires. Baseline data are obtained from the FRENCHIE registry. Each participant will be subsequently followed based on data from the National Health Data System (SNDS). Over a period of 4 years, the AMI-Sleep study is expected to recruit approximately 2000 participants. Assuming at least a 10% rate of incident cardiovascular events over 1 year, there would be an estimated 200 events during the first year of follow-up that would be sufficient in multivariable analysis. The primary objective is to describe the prevalence and severity of SDB in AMI and to analyse the association between the type and severity of SDB (based on the apnoea-hypopnoea index) and the occurrence of cardiovascular events (incident acute coronary syndrome, transient ischaemic attack, stroke) or all-cause death after AMI. Secondary objectives include determining the association between the presence of SAS and coronary artery disease severity, in-hospital mortality, morbidity events, healthcare consumption and related costs. ETHICS AND DISSEMINATION: Eligible individuals are provided with information about the AMI-Sleep study and provided written informed consent. The protocol was approved by the regional Ethics Committee (CPP Ouest II - Angers, RCB N°2018-A00719-46) on 17 February 2019, is registered on ClinicalTrials.gov (NCT04064593) and started in January 2019 with the expected publication of primary outcome results in 2025. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT04064593.
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