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

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362385
• Other study ID #: 2013025
• Status: Completed
• Start date: May 2015
• Est. completion date: December 2020

Study information

• Verified date: September 2021
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2160
• Est. completion date: December 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Other:
• Patients with OSA based on sleep study
Polysomnography or Polygraphy
• Patients without OSA based on sleep study
Polysomnography or Polygraphy

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebrovascular events (MACCEs)	Including cardiovascular death, myocardial infarction, stroke, ischemia-driven revascularization, and hospitalization for unstable angina or heart failure	Median 24 months
Secondary	Cardiovascular death		Median 24 months
Secondary	All-cause mortality		Median 24 months
Secondary	Hospitalization for unstable angina		Median 24 months
Secondary	Ischemia-driven revascularization		Median 24 months
Secondary	Any repeat revascularization		Median 24 months
Secondary	Myocardial salvage index (assessed by CMR)		3 months
Secondary	Relative proliferation volume within stent segment (% of stent volume)		12 months
Secondary	MACCEs	Effect of continuous positive airway pressure (CPAP) treatment on MACCEs in patients with OSA and ACS	Median 24 months