NCT04064593

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

SDB Prevalence and Cardiovascular Outcomes of MI Survivors

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,007 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Myocardial Infarction
• Sleep Apnea

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Polygraphy	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.

Timeline

• Start date: 2019-04-11
• Primary completion: 2024-01-11
• Completion: 2024-09-01
• First posted: 2019-08-22
• Last updated: 2024-02-14

Locations

1 site across 1 country: France