Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04064593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2019-08-05
Brief Title:
Sleep Disordered Breathing SDB Prevalence and Cardiovascular Outcomes of Myocardial Infarction MI Survivors
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
SDB Prevalence and Cardiovascular Outcomes of MI Survivors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMISLEEP
Brief Summary:
The AMISLEEP study is nested in the FRENCHIE registry
The objective is to use routine clinical and polygraphic data to capture SDBSAS Sleep Disordered BreathingSleep 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 SDBSAS treatment can improve this risk
The objective is to use routine clinical and polygraphic data to capture SDBSAS Sleep Disordered BreathingSleep 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 SDBSAS 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None