OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients
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| ClinicalTrials.gov Identifier: NCT03362385 |
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Recruitment Status :
Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
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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 |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
| OSA |
Other: Patients with OSA based on sleep study
Polysomnography or Polygraphy |
| Non-OSA |
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age ≥18 years old
- Admission with an ACS (including STEMI, NSTEMI, and unstable angina)
- Written informed consent
Exclusion Criteria:
- Cardiogenic shock (systolic blood pressure <90mmHg)
- Cardiac arrest on admission or during hospitalization
- Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep duration <4h/night)
- Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index (AHI) ≥10/h)
- Previous or current use of CPAP
- Known or planned pregnancy
- Severe comorbidities: eg. malignancy (life expectancy <2 years)
- Patients who cannot tolerate the sleep study or refuse it
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, MD | 86-10-84005255 | spaceeye123@126.com |
| China | |
| Beijing Anzhen Hospital, Capital Medical University | Recruiting |
| Beijing, China, 100029 | |
| Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 spnie@ccmu.edu.cn | |
| Principal Investigator: Shao-Ping Nie, MD, PhD | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shao-Ping Nie, Director, Emergency & Critical Care Center, Professor of Medicine, Beijing Anzhen Hospital |
| ClinicalTrials.gov Identifier: | NCT03362385 History of Changes |
| Other Study ID Numbers: |
2013025 |
| First Posted: | December 5, 2017 Key Record Dates |
| Last Update Posted: | December 5, 2017 |
| Last Verified: | November 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Shao-Ping Nie, Beijing Anzhen Hospital:
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Obstructive sleep apnea Acute coronary syndrome Continuous positive airway pressure Outcome |
Additional relevant MeSH terms:
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Syndrome Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Acute Coronary Syndrome Disease Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |