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

Acute Myocardial Infarction Clinical Trial

Official title: SDB Prevalence and Cardiovascular Outcomes of MI Survivors

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Sleep Apnea
• Sleep Apnea Syndromes

• NCT number: NCT04064593
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 11, 2019
• Completion date: September 2024