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Clinical Trials/NCT03362385
NCT03362385
Completed
Not Applicable

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

Beijing Anzhen Hospital1 site in 1 country2,160 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea of Adult
Sponsor
Beijing Anzhen Hospital
Enrollment
2160
Locations
1
Primary Endpoint
Major adverse cardiac and cerebrovascular events (MACCEs)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
December 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Anzhen Hospital
Responsible Party
Principal Investigator
Principal Investigator

Shao-Ping Nie

Director, Emergency & Critical Care Center, Professor of Medicine

Beijing Anzhen Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Cardiovascular death(Median 24 months)
  • Hospitalization for unstable angina(Median 24 months)
  • Any repeat revascularization(Median 24 months)
  • Relative proliferation volume within stent segment (% of stent volume)(12 months)
  • All-cause mortality(Median 24 months)
  • Myocardial salvage index (assessed by CMR)(3 months)
  • Ischemia-driven revascularization(Median 24 months)
  • MACCEs(Median 24 months)

Study Sites (1)

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