Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064593
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Sleep Apnea Diagnostic Test: Polygraphy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SDB Prevalence and Cardiovascular Outcomes of MI Survivors
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064593


Contacts
Layout table for location contacts
Contact: Marie-Pia D'ORTHO 33(0)1 402 58401 marie-pia.dortho@aphp.fr
Contact: Philippe Gabriel STEG 01 40 25 80 80 gabriel.steg@aphp.fr

Locations
Layout table for location information
France
Hôpital Bichat, AP-HP Recruiting
Paris, France
Contact: Philippe Gabriel STEG    01 40 25 80 80    gabriel.steg@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Research Agency, France
Investigators
Layout table for investigator information
Principal Investigator: Philippe Gabriel STEG Assistance Publique - Hôpitaux de Paris

Publications:

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04064593     History of Changes
Other Study ID Numbers: P171101J
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Myocardial Infarction
Sleep Apnea
Outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases