Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors (AMISLEEP)
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|ClinicalTrials.gov Identifier: NCT04064593|
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
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|
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 (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064593
|Contact: Marie-Pia D'ORTHO||33(0)1 402 firstname.lastname@example.org|
|Contact: Philippe Gabriel STEG||01 40 25 80 email@example.com|
|Hôpital Bichat, AP-HP||Recruiting|
|Contact: Philippe Gabriel STEG 01 40 25 80 80 firstname.lastname@example.org|
|Principal Investigator:||Philippe Gabriel STEG||Assistance Publique - Hôpitaux de Paris|