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

February 13, 2024 updated by: Assistance Publique - Hôpitaux de Paris

SDB Prevalence and Cardiovascular Outcomes of 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2007

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Hôpital Bichat, AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polygraphy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through the end of hospitalization, an average of 5 days
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.
Through the end of hospitalization, an average of 5 days
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.
12 months follow up
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.
12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

National Research Agency, France

Investigators

  • Principal Investigator: Philippe Gabriel STEG, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2019

Primary Completion (Actual)

January 11, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P171101J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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