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

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03362385

Collaborator

(none)

2,160

Enrollment

Location

67.1

Actual Duration (Months)

32.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea of Adult Acute Coronary Syndrome	Other: Patients with OSA based on sleep study Other: Patients without OSA based on sleep study

Study Design

Study Type:

Observational

Actual Enrollment :

2160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
OSA	Other: Patients with OSA based on sleep study Polysomnography or Polygraphy
Non-OSA	Other: Patients without OSA based on sleep study Polysomnography or Polygraphy

Arm

Intervention/Treatment

OSA

Other: Patients with OSA based on sleep study

Polysomnography or Polygraphy

Non-OSA

Other: Patients without OSA based on sleep study

Polysomnography or Polygraphy

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
Myocardial salvage index (assessed by CMR) [3 months]
Relative proliferation volume within stent segment (% of stent volume) [12 months]
MACCEs [Median 24 months]
Effect of continuous positive airway pressure (CPAP) treatment on MACCEs in patients with OSA and ACS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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