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

NCT03362385 | Completed

• 1 other identifier: 2013025
• Study Type: observational
• Target: 2,160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea of Adult; Acute Coronary Syndrome

Keywords

Obstructive sleep apnea; Acute coronary syndrome; Continuous positive airway pressure; Outcome

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebrovascular events (MACCEs)

  Including cardiovascular death, myocardial infarction, stroke, ischemia-driven revascularization, and hospitalization for unstable angina or heart failure

  Median 24 months

Secondary Outcomes (8)

• Cardiovascular death

  Median 24 months

• All-cause mortality

  Median 24 months

• Hospitalization for unstable angina

  Median 24 months

• Ischemia-driven revascularization

  Median 24 months

• Any repeat revascularization

  Median 24 months

Study Arms (2)

OSA

Other: Patients with OSA based on sleep study

Non-OSA

Other: Patients without OSA based on sleep study

Interventions

Patients with OSA based on sleep study OTHER

Polysomnography or Polygraphy

OSA

Patients without OSA based on sleep study OTHER

Polysomnography or Polygraphy

Non-OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In-hospital patients with ACS and undergoing sleep study

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

Related Publications (13)

• 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.

  PMID: 40776960 DERIVED

• 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.

  PMID: 40475723 DERIVED

• 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.

  PMID: 39395961 DERIVED

• 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.

  PMID: 39307479 DERIVED

• 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.

  PMID: 38098080 DERIVED

• 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.

  PMID: 37369551 DERIVED

• 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.

  PMID: 36859391 DERIVED

• 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.

  PMID: 36764513 DERIVED

• 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.

  PMID: 36329414 DERIVED

• 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.

  PMID: 36073641 DERIVED

• 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.

  PMID: 30819182 DERIVED

• 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.

  PMID: 30139013 DERIVED

• 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.

  PMID: 30060328 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Emergency & Critical Care Center, Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: December 5, 2017
• Study Start: May 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

CN (1)