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

Assistance Publique - Hôpitaux de Paris

Status: Active, not recruiting

Conditions: Sleep Apnea; Acute Myocardial Infarction

Treatments: Diagnostic Test: Polygraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT04064593

P171101J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,007 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,007 participants in 1 patient group

Polygraphy

Experimental group

Treatment:

Diagnostic Test: Polygraphy