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

Capital Medical University

Status: Completed

Conditions: Obstructive Sleep Apnea of Adult; Acute Coronary Syndrome

Treatments: Other: Patients with OSA based on sleep study; Other: Patients without OSA based on sleep study

Study type: Observational

Funder types: Other

Identifiers

NCT03362385

2013025

Details and patient eligibility

About

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.

Enrollment: 2,160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,160 participants in 2 patient groups

OSA

Treatment:

Other: Patients with OSA based on sleep study

Non-OSA

Treatment:

Other: Patients without OSA based on sleep study