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

Primary Purpose

Acute Myocardial Infarction, Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polygraphy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, Sleep Apnea, Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Bichat, AP-HPRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Polygraphy

Arm Description

Outcomes

Primary Outcome Measures

Contribution of SDB/SAS to events after AMI
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

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

Full Information

First Posted
August 5, 2019
Last Updated
April 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Research Agency, France
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1. Study Identification

Unique Protocol Identification Number
NCT04064593
Brief Title
Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors
Acronym
AMISLEEP
Official Title
SDB Prevalence and Cardiovascular Outcomes of MI Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Research Agency, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Sleep Apnea
Keywords
Acute Myocardial Infarction, Sleep Apnea, Outcomes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polygraphy
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Polygraphy
Intervention Description
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 Measure Information:
Title
Contribution of SDB/SAS to events after AMI
Description
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.
Time Frame
12 months follow up
Secondary Outcome Measure Information:
Title
Associations between presence, type and severity of SDB and the severity of the initial coronary disease
Description
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
Time Frame
Through the end of hospitalization, an average of 5 days
Title
Validate the Berlin questionnaire to screen for obstructive and central SDB/SAS in the AMI patients
Description
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.
Time Frame
Through the end of hospitalization, an average of 5 days
Title
Evaluate health care related costs during the year following hospital discharge.
Description
Health care related costs for SDB considered will be: confirmation of SDB by an additional polysomnography, SDB treatments.
Time Frame
12 months follow up
Title
Comparison of health care consumption between SDB and non-SDB patients
Description
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.
Time Frame
12 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Pia D'ORTHO
Phone
33(0)1 402 58401
Email
marie-pia.dortho@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Gabriel STEG
Phone
01 40 25 80 80
Email
gabriel.steg@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Gabriel STEG
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat, AP-HP
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Gabriel STEG
Phone
01 40 25 80 80
Email
gabriel.steg@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
8464434
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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PubMed Identifier
27810127
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Jesus EV, Dias-Filho EB, Mota Bde M, Souza Ld, Marques-Santos C, Rocha JB, Oliveira JL, Sousa AC, Barreto-Filho JA. Suspicion of obstructive sleep apnea by Berlin Questionnaire predicts events in patients with acute coronary syndrome. Arq Bras Cardiol. 2010 Sep;95(3):313-20. doi: 10.1590/s0066-782x2010005000103. Epub 2010 Aug 6.
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Citation
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Results Reference
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Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors

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