Clinical trial NCT03362385: OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea of Adult
Acute Coronary Syndrome
Keywords: Obstructive sleep apnea
Acute coronary syndrome
Continuous positive airway pressure
Outcome
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 2160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-hospital patients with ACS and undergoing sleep study

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCEs)
timeFrame: Median 24 months
Secondary outcomes:
measure: Cardiovascular death
timeFrame: Median 24 months
measure: All-cause mortality
timeFrame: Median 24 months
measure: Hospitalization for unstable angina
timeFrame: Median 24 months
measure: Ischemia-driven revascularization
timeFrame: Median 24 months
measure: Any repeat revascularization
timeFrame: Median 24 months
measure: Myocardial salvage index (assessed by CMR)
timeFrame: 3 months
measure: Relative proliferation volume within stent segment (% of stent volume)
timeFrame: 12 months
measure: MACCEs
timeFrame: Median 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References:
citation: Li Z, Miao H, Zhang S, Fan J, Yan Y, Gong W, Zheng W, Wang X, Que B, Ai H, Zhang L, Nie S. The value of nurse-led anthropometric and oropharyngeal measurements combined with STOP-Bang questionnaire in screening for obstructive sleep apnea in patients with acute coronary syndrome: a prospective cohort study. BMC Pulm Med. 2022 Nov 3;22(1):396. doi: 10.1186/s12890-022-02200-x.
citation: Lv Q, Jiao X, Yu H, Sun Q, Li F, Wang Y, Sun H, Du Z, Li L, Hu C, Zhang M, Nie S, Qin Y. ANGPTL3 and Cardiovascular Outcomes in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea. J Am Heart Assoc. 2022 Sep 20;11(18):e025955. doi: 10.1161/JAHA.122.025955. Epub 2022 Sep 8.
citation: Zeng Y, Yang S, Wang X, Fan J, Nie S, Wei Y. Prognostic impact of residual SYNTAX score in patients with obstructive sleep apnea and acute coronary syndrome: a prospective cohort study. Respir Res. 2019 Feb 28;20(1):43. doi: 10.1186/s12931-019-1008-z.
citation: Zhou SH, Wang X, Fan JY, Gong W, Zhao GQ, Hao W, Li AB, Guo RF, Shi H, Li ZX, Nie SP, Wei YX. [Prospective cohort study on the impact of moderate/severe obstructive sleep apnea on the prognosis of patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2018 Aug 24;46(8):622-628. doi: 10.3760/cma.j.issn.0253-3758.2018.08.009. Chinese.
citation: Zhao GQ, Wang X, Fan JY, Gong W, Hao W, Zhou SH, Li AB, Guo RF, Shi H, Li ZX, Nie SP, Wei YX. [Association between hypothyroidism and sleep breathing disorders in patients with coronary heart disease]. Zhonghua Nei Ke Za Zhi. 2018 Aug 1;57(8):571-575. doi: 10.3760/cma.j.issn.0578-1426.2018.08.007. Chinese.