OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients
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|ClinicalTrials.gov Identifier: NCT03362385|
Recruitment Status : Unknown
Verified November 2017 by Shao-Ping Nie, Beijing Anzhen Hospital.
Recruitment status was: Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
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|
|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 Type :||Observational|
|Estimated Enrollment :||2000 participants|
|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 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Other: Patients with OSA based on sleep study
Polysomnography or Polygraphy
Other: Patients without OSA based on sleep study
Polysomnography or Polygraphy
- Major adverse cardiac and cerebrovascular events (MACCEs) [ Time Frame: Median 24 months ]Including cardiovascular death, myocardial infarction, stroke, ischemia-driven revascularization, and hospitalization for unstable angina or heart failure
- Cardiovascular death [ Time Frame: Median 24 months ]
- All-cause mortality [ Time Frame: Median 24 months ]
- Hospitalization for unstable angina [ Time Frame: Median 24 months ]
- Ischemia-driven revascularization [ Time Frame: Median 24 months ]
- Any repeat revascularization [ Time Frame: Median 24 months ]
- Myocardial salvage index (assessed by CMR) [ Time Frame: 3 months ]
- Relative proliferation volume within stent segment (% of stent volume) [ Time Frame: 12 months ]
- MACCEs [ Time Frame: Median 24 months ]Effect of continuous positive airway pressure (CPAP) treatment on MACCEs in patients with OSA and ACS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362385
|Contact: Xiao Wang, MDfirstname.lastname@example.org|
|Beijing Anzhen Hospital, Capital Medical University||Recruiting|
|Beijing, China, 100029|
|Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 email@example.com|
|Principal Investigator: Shao-Ping Nie, MD, PhD|