Skip to main content
OpenTrials
Completed

NCT Number: NCT03362385

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Patients with OSA based on sleep study

Other

Polysomnography or Polygraphy

Patients without OSA based on sleep study

Other

Polysomnography or Polygraphy

Primary outcomes

  1. Major adverse cardiac and cerebrovascular events (MACCEs)

    Time frame: Median 24 months

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

Secondary outcomes

  1. Cardiovascular death

    Time frame: Median 24 months

  2. All-cause mortality

    Time frame: Median 24 months

  3. Hospitalization for unstable angina

    Time frame: Median 24 months

  4. Ischemia-driven revascularization

    Time frame: Median 24 months

  5. Any repeat revascularization

    Time frame: Median 24 months

  6. Myocardial salvage index (assessed by CMR)

    Time frame: 3 months

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

    Time frame: 12 months

  8. MACCEs

    Time frame: Median 24 months

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

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2017
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.