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COMPLETED
NCT04064593
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: SDB Prevalence and Cardiovascular Outcomes of MI Survivors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2007

Start Date

2019-04-09

Completion Date

2023-12-03

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hôpital Bichat, AP-HP

Paris, France