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

Completed

• Conditions: Obstructive Sleep Apnea of Adult; Acute Coronary Syndrome
• Interventions: Other: Patients with OSA based on sleep study; Other: Patients without OSA based on sleep study

• Registration Number: NCT03362385
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Primary Completion: 2020-01
• Study Completion: 2020-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSA	Patients with OSA based on sleep study	-
Non-OSA	Patients without OSA based on sleep study	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cardiovascular death	Median 24 months
Hospitalization for unstable angina	Median 24 months
Any repeat revascularization	Median 24 months
All-cause mortality	Median 24 months
Relative proliferation volume within stent segment (% of stent volume)	12 months
Myocardial salvage index (assessed by CMR)	3 months
Ischemia-driven revascularization	Median 24 months
MACCEs	Median 24 months	Effect of continuous positive airway pressure (CPAP) treatment on MACCEs in patients with OSA and ACS

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China