OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients

NCT ID: NCT03362385

Last Updated: 2021-09-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

2160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-12-31

Brief Summary

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Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults that has been strongly associated with various forms of cardiovascular disease. Compared to the general population, OSA occurs more often in patients with acute coronary syndrome (ACS). Although percutaneous coronary intervention (PCI) is nowadays part of standard therapy and optimal medical therapy has been used to manage traditional risk factors, the long-term cardiovascular outcomes after index ACS remain suboptimal.

Some preliminary data suggest OSA is associated with higher risk of subsequent cardiovascular events in ACS patients. However, the study population was heterogeneous and these studies were not done in the context of new-generation drug-eluting stents and intensive antiplatelet therapy, thus precluding definite conclusions. Furthermore, a cardioprotective role of OSA in the context of acute myocardial infarction (AMI), via ischemic preconditioning, has also been postulated.

Due to the inconsistent evidence, the investigators performed a large-scale, prospective cohort study to delineate the whole picture of the association of OSA with short- and long-term outcomes of patients with ACS. Whether treatment of OSA (eg. continuous positive airway pressure (CPAP)) would prevent these events will also be evaluated. Moreover, the investigators will assess the potential mechanisms of OSA-induced atherosclerosis and myocardial injury in ACS patients.

Detailed Description

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Conditions

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Obstructive Sleep Apnea of Adult Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OSA

Patients with OSA based on sleep study

Intervention Type OTHER

Polysomnography or Polygraphy

Non-OSA

Patients without OSA based on sleep study

Intervention Type OTHER

Polysomnography or Polygraphy

Interventions

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Patients with OSA based on sleep study

Polysomnography or Polygraphy

Intervention Type OTHER

Patients without OSA based on sleep study

Polysomnography or Polygraphy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years old
2. Admission with an ACS (including STEMI, NSTEMI, and unstable angina)
3. Written informed consent

Exclusion Criteria

1. Cardiogenic shock (systolic blood pressure \<90mmHg)
2. Cardiac arrest on admission or during hospitalization
3. Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep duration \<4h/night)
4. Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index (AHI) ≥10/h)
5. Previous or current use of CPAP
6. Known or planned pregnancy
7. Severe comorbidities: eg. malignancy (life expectancy \<2 years)
8. Patients who cannot tolerate the sleep study or refuse it
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shao-Ping Nie

Director, Emergency & Critical Care Center, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Site Status

Countries

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China

References

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Qiu Y, Li Z, Hao W, Liu X, Guo Q, Guo Y, Que B, Gong W, Zheng W, Wang X, Nie S. Association of Obstructive Sleep Apnea With Cardiovascular Events in Acute Coronary Syndrome Patients With or Without Excessive Daytime Sleepiness: A Prospective Cohort Study. Rev Cardiovasc Med. 2025 Jul 28;26(7):33439. doi: 10.31083/RCM33439. eCollection 2025 Jul.

Reference Type DERIVED
PMID: 40776960 (View on PubMed)

Zhang Y, Xu D, Zheng W, Hao W, Zhen L, Yan Y, Wang X, Nie S. Impact of Obstructive Sleep Apnea and Triglyceride Glucose Index on Cardiovascular Events in Acute Coronary Syndrome Patients: A Post-Hoc Analysis of the OSA-ACS Study. Rev Cardiovasc Med. 2025 May 21;26(5):36205. doi: 10.31083/RCM36205. eCollection 2025 May.

Reference Type DERIVED
PMID: 40475723 (View on PubMed)

Zhou Y, Gong W, Yan Y, Wang X, Zheng W, Que B, Li S, Zhang Z, Chen X, Fan J, Zhao W, Xin Q, Ai H, Nie S. Prognostic implications of obstructive sleep apnea in patients with unstable angina stratified by remnant cholesterol and triglyceride: a prospective cohort study. BMC Cardiovasc Disord. 2024 Oct 12;24(1):549. doi: 10.1186/s12872-024-04214-1.

Reference Type DERIVED
PMID: 39395961 (View on PubMed)

Zhang Z, Ai H, Yan M, Zheng W, Yan Y, Wang X, Fan J, Que B, Li S, Wang G, Gong W, Nie S. Prognostic effect of obstructive sleep apnea in acute coronary syndrome patients with heart failure. Respir Med. 2024 Nov-Dec;234:107814. doi: 10.1016/j.rmed.2024.107814. Epub 2024 Sep 21.

Reference Type DERIVED
PMID: 39307479 (View on PubMed)

Chen X, Zhen L, Ai H, Que B, Fan J, Wang X, Yan Y, Li S, Zhang Z, Zhou Y, Gong W, Nie S. Prognostic implications of obstructive sleep apnea in patients with acute coronary syndrome stratified by homocysteine level: a prospective cohort study. Respir Res. 2023 Dec 14;24(1):313. doi: 10.1186/s12931-023-02627-8.

Reference Type DERIVED
PMID: 38098080 (View on PubMed)

Wang G, Miao H, Hao W, Zhao G, Yan Y, Gong W, Fan J, Ai H, Que B, Wang X, Nie S. Association of obstructive sleep apnoea with long-term cardiovascular events in patients with acute coronary syndrome with or without hypertension: insight from the OSA-ACS project. BMJ Open Respir Res. 2023 Jun;10(1):e001662. doi: 10.1136/bmjresp-2023-001662.

Reference Type DERIVED
PMID: 37369551 (View on PubMed)

Wang B, Hao W, Fan J, Yan Y, Gong W, Zheng W, Que B, Ai H, Wang X, Nie S. Clinical significance of obstructive sleep apnea in patients with acute coronary syndrome with or without prior stroke: a prospective cohort study. Eur J Med Res. 2023 Mar 1;28(1):107. doi: 10.1186/s40001-023-01071-0.

Reference Type DERIVED
PMID: 36859391 (View on PubMed)

Hao W, Wang X, Fan J, Guo R, Gong W, Yan Y, Zheng W, Que B, Ai H, Ma C, Ma X, Nie S. Prognostic Implications of OSA in Acute Coronary Syndrome by Obesity Status. Chest. 2023 Jul;164(1):219-230. doi: 10.1016/j.chest.2023.02.001. Epub 2023 Feb 9.

Reference Type DERIVED
PMID: 36764513 (View on PubMed)

Li Z, Miao H, Zhang S, Fan J, Yan Y, Gong W, Zheng W, Wang X, Que B, Ai H, Zhang L, Nie S. The value of nurse-led anthropometric and oropharyngeal measurements combined with STOP-Bang questionnaire in screening for obstructive sleep apnea in patients with acute coronary syndrome: a prospective cohort study. BMC Pulm Med. 2022 Nov 3;22(1):396. doi: 10.1186/s12890-022-02200-x.

Reference Type DERIVED
PMID: 36329414 (View on PubMed)

Lv Q, Jiao X, Yu H, Sun Q, Li F, Wang Y, Sun H, Du Z, Li L, Hu C, Zhang M, Nie S, Qin Y. ANGPTL3 and Cardiovascular Outcomes in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea. J Am Heart Assoc. 2022 Sep 20;11(18):e025955. doi: 10.1161/JAHA.122.025955. Epub 2022 Sep 8.

Reference Type DERIVED
PMID: 36073641 (View on PubMed)

Zeng Y, Yang S, Wang X, Fan J, Nie S, Wei Y. Prognostic impact of residual SYNTAX score in patients with obstructive sleep apnea and acute coronary syndrome: a prospective cohort study. Respir Res. 2019 Feb 28;20(1):43. doi: 10.1186/s12931-019-1008-z.

Reference Type DERIVED
PMID: 30819182 (View on PubMed)

Zhou SH, Wang X, Fan JY, Gong W, Zhao GQ, Hao W, Li AB, Guo RF, Shi H, Li ZX, Nie SP, Wei YX. [Prospective cohort study on the impact of moderate/severe obstructive sleep apnea on the prognosis of patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2018 Aug 24;46(8):622-628. doi: 10.3760/cma.j.issn.0253-3758.2018.08.009. Chinese.

Reference Type DERIVED
PMID: 30139013 (View on PubMed)

Zhao GQ, Wang X, Fan JY, Gong W, Hao W, Zhou SH, Li AB, Guo RF, Shi H, Li ZX, Nie SP, Wei YX. [Association between hypothyroidism and sleep breathing disorders in patients with coronary heart disease]. Zhonghua Nei Ke Za Zhi. 2018 Aug 1;57(8):571-575. doi: 10.3760/cma.j.issn.0578-1426.2018.08.007. Chinese.

Reference Type DERIVED
PMID: 30060328 (View on PubMed)

Other Identifiers

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2013025

Identifier Type: -

Identifier Source: org_study_id

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