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Obstructive Sleep Apnea of AdultNCT03362385

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

An observational study of Obstructive Sleep Apnea of Adult and Acute Coronary Syndrome, run by Beijing Anzhen Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patients with OSA based on sleep study and Patients without OSA based on sleep study
How many people
2,160 participants
Where
1 siteChina
Study dates
May 2015to Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In-hospital patients with ACS and undergoing sleep study

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, 100029

Other trials in China

About this study

Official title: Impact of Obstructive Sleep Apnea and Continuous Positive Airway Pressure Therapy on Outcomes in Patients With Acute Coronary Syndrome: The OSA-ACS Project

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.

Being tested
Patients with OSA based on sleep study, Patients without OSA based on sleep study
Keywords
Obstructive sleep apnea, Acute coronary syndrome, Continuous positive airway pressure, Outcome
Medical subject headings
Acute Coronary Syndrome, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients with OSA based on sleep studyOther

    Polysomnography or Polygraphy

  • Patients without OSA based on sleep studyOther

    Polysomnography or Polygraphy

Study groups in NCT03362385
Study groupRoleWhat they receive
OSANot described
Receives: Other: Patients with OSA based on sleep study
Non-OSANot described
Receives: Other: Patients without OSA based on sleep study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Median 24 months

Secondary outcomes (8)

  1. Cardiovascular death

    Measured: Median 24 months

  2. All-cause mortality

    Measured: Median 24 months

  3. Hospitalization for unstable angina

    Measured: Median 24 months

  4. Ischemia-driven revascularization

    Measured: Median 24 months

  5. Any repeat revascularization

    Measured: Median 24 months

  6. Myocardial salvage index (assessed by CMR)

    Measured: 3 months

  7. Relative proliferation volume within stent segment (% of stent volume)

    Measured: 12 months

  8. MACCEs

    Effect of continuous positive airway pressure (CPAP) treatment on MACCEs in patients with OSA and ACS

    Measured: Median 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2017
  2. Study startMay 2015
  3. Primary completionJan 2020
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03362385
Sponsor's protocol ID
2013025
Status last verified
Sep 2021
First submitted
7 Nov 2017
Last updated
5 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gong W, Chen X, Zhao W, Du J, Zhang Z, Fan J, Wang X, Yan Y, Ai H, Li S, Zhou Y, Nie S. Obstructive sleep apnea increases recurrent cardiovascular event risk in younger but not older patients with acute coronary syndrome: a prospective cohort study. Sleep Med. 2026 Jun;142:108829. doi: 10.1016/j.sleep.2026.108829. Epub 2026 Feb 9.

    PubMed 41719768

  • 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.

    PubMed 40776960

  • 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.

    PubMed 40475723

  • Liu X, Wang B, Hao W, Qiu Y, Guo Q, Guo Y, Xin Q, Fan J, Que B, Gong W, Zheng W, Wang X, Nie S. Association of Obstructive Sleep Apnea and Nocturnal Hypoxemia With the Circadian Rhythm of Myocardial Infarction. J Am Heart Assoc. 2025 Feb 4;14(3):e036729. doi: 10.1161/JAHA.124.036729. Epub 2025 Jan 27.

    PubMed 39868516

  • 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.

    PubMed 39395961

  • 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.

    PubMed 39307479

  • 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.

    PubMed 38098080

  • 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.

    PubMed 37369551

  • 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.

    PubMed 36859391

  • 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.

    PubMed 36764513

  • 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.

    PubMed 36329414

  • 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.

    PubMed 36073641

  • 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.

    PubMed 30819182

  • 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.

    PubMed 30139013

  • 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.

    PubMed 30060328

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea of Adult and Acute Coronary Syndrome, run by Beijing Anzhen Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac and cerebrovascular events (MACCEs) (time frame: Median 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03362385, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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