Skip to main content
OpenTrials
Completed

NCT Number: NCT04064593

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myocardial Infarction Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Bichat, AP-HP

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polygraphy

Diagnostic Test

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.

Primary outcomes

  1. Contribution of SDB/SAS to events after AMI

    Time frame: 12 months follow up

    Contribution of SDB/SAS to incident cardiovascular events and mortality during the first year following acute myocardial infraction :

    Cardiovascular event will be defined as incident acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke or death of any cause after discharge during the first year following the AMI event. Time from discharge to the first event will be considered.

Secondary outcomes

  1. Associations between presence, type and severity of SDB and the severity of the initial coronary disease

    Time frame: Through the end of hospitalization, an average of 5 days

    The severity of the index event (number of stents combined with revascularizations and coronary bypass) will be compared to type and severity of SDB (apnea-hypopnea index AHI), to evaluate if both are associated

  2. Validate the Berlin questionnaire to screen for obstructive and central SDB/SAS in the AMI patients

    Time frame: Through the end of hospitalization, an average of 5 days

    Concordance between the result of the Berlin questionnaire and the presence of obstructive SDB/SAS measured by polygraphy as reference and concordance between the result of the Berlin questionnaire and the presence of central SDB/SAS measured by polygraphy as reference.

  3. Evaluate health care related costs during the year following hospital discharge.

    Time frame: 12 months follow up

    Health care related costs for SDB considered will be: confirmation of SDB by an additional polysomnography, SDB treatments.

  4. Comparison of health care consumption between SDB and non-SDB patients

    Time frame: 12 months follow up

    Health care consumption and health care related costs will be compared between patients :

    • without SDB
    • with mild SDB (AHI between 5 and 14/h)
    • with moderate SDB (AHI between 15h to 29/h)
    • with severe SDB (AHI ≥ 30/h)

    Health care consumption and health care related costs considered will be AMI recurrence, incident TIA/stroke, cardiac arrhythmia, heart decompensation, diabetes, depression and cancers.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • National Research Agency, France

Registry information

Official study title

SDB Prevalence and Cardiovascular Outcomes of MI Survivors

Acronym: AMISLEEP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2019
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.