Clinical trial NCT04064593: Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors
Official title: SDB Prevalence and Cardiovascular Outcomes of MI Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Sleep Apnea
Keywords: Acute Myocardial Infarction
Sleep Apnea
Outcomes
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2019-08-22
Enrollment: 2007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Contribution of SDB/SAS to events after AMI
timeFrame: 12 months follow up
Secondary outcomes:
measure: Associations between presence, type and severity of SDB and the severity of the initial coronary disease
timeFrame: Through the end of hospitalization, an average of 5 days
measure: Validate the Berlin questionnaire to screen for obstructive and central SDB/SAS in the AMI patients
timeFrame: Through the end of hospitalization, an average of 5 days
measure: Evaluate health care related costs during the year following hospital discharge.
timeFrame: 12 months follow up
measure: Comparison of health care consumption between SDB and non-SDB patients
timeFrame: 12 months follow up
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat, AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Gabriel STEG
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, Mooser V, Preisig M, Malhotra A, Waeber G, Vollenweider P, Tafti M, Haba-Rubio J. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015 Apr;3(4):310-8. doi: 10.1016/S2213-2600(15)00043-0. Epub 2015 Feb 12.
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