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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03362385
Enrollment
2160
Registered
2017-12-05
Start date
2015-05-31
Completion date
2020-12-31
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Obstructive Sleep Apnea of Adult

Keywords

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

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.

Interventions

OTHERPatients with OSA based on sleep study

Polysomnography or Polygraphy

OTHERPatients without OSA based on sleep study

Polysomnography or Polygraphy

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiac and cerebrovascular events (MACCEs)Median 24 monthsIncluding cardiovascular death, myocardial infarction, stroke, ischemia-driven revascularization, and hospitalization for unstable angina or heart failure

Secondary

MeasureTime frameDescription
All-cause mortalityMedian 24 months
Hospitalization for unstable anginaMedian 24 months
Ischemia-driven revascularizationMedian 24 months
Cardiovascular deathMedian 24 months
Myocardial salvage index (assessed by CMR)3 months
Relative proliferation volume within stent segment (% of stent volume)12 months
MACCEsMedian 24 monthsEffect of continuous positive airway pressure (CPAP) treatment on MACCEs in patients with OSA and ACS
Any repeat revascularizationMedian 24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026