Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors
NCT ID: NCT04064593
Last Updated: 2024-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2007 participants
INTERVENTIONAL
2019-04-11
2024-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Polygraphy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Signed consent for AMI-Sleep study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Research Agency, France
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Philippe Gabriel STEG
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Bichat, AP-HP
Paris, , France
Countries
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References
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Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.
Crawford-Achour E, Dauphinot V, Martin MS, Tardy M, Gonthier R, Barthelemy JC, Roche F. Protective Effect of Long-Term CPAP Therapy on Cognitive Performance in Elderly Patients with Severe OSA: The PROOF Study. J Clin Sleep Med. 2015 Apr 15;11(5):519-24. doi: 10.5664/jcsm.4694.
Cadelis G, Fayad Y Monteagudo OE. [Prevalence of symptoms and risk of obstructive sleep apnea syndrome assessed by the Berlin Questionnaire among professionals of a health facility]. Rev Epidemiol Sante Publique. 2016 Dec;64(6):405-414. doi: 10.1016/j.respe.2016.06.332. Epub 2016 Oct 31. French.
Tishler PV, Larkin EK, Schluchter MD, Redline S. Incidence of sleep-disordered breathing in an urban adult population: the relative importance of risk factors in the development of sleep-disordered breathing. JAMA. 2003 May 7;289(17):2230-7. doi: 10.1001/jama.289.17.2230.
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.
Levendowski D, Steward D, Woodson BT, Olmstead R, Popovic D, Westbrook P. The impact of obstructive sleep apnea variability measured in-lab versus in-home on sample size calculations. Int Arch Med. 2009 Jan 2;2(1):2. doi: 10.1186/1755-7682-2-2.
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.
Gus M, Goncalves SC, Martinez D, de Abreu Silva EO, Moreira LB, Fuchs SC, Fuchs FD. Risk for Obstructive Sleep Apnea by Berlin Questionnaire, but not daytime sleepiness, is associated with resistant hypertension: a case-control study. Am J Hypertens. 2008 Jul;21(7):832-5. doi: 10.1038/ajh.2008.184. Epub 2008 May 1.
Balagny P, D'Ortho MP, Berard L, Rousseau A, Gourmelen J, Ravaud P, Durand-Zaleski I, Simon T, Steg PG; AMI SLEEP investigators. AMI-Sleep: protocol for a prospective study of sleep-disordered breathing/sleep apnoea syndrome and incident cardiovascular events after acute myocardial infarction. BMJ Open. 2025 Feb 18;15(2):e090093. doi: 10.1136/bmjopen-2024-090093.
Other Identifiers
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P171101J
Identifier Type: -
Identifier Source: org_study_id
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