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

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ClinicalTrials.gov Identifier: NCT03362385
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Shao-Ping Nie, Beijing Anzhen Hospital

November 7, 2017
December 5, 2017
December 5, 2017
May 2015
December 2019   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients
Impact of Obstructive Sleep Apnea and Continuous Positive Airway Pressure Therapy on Outcomes in Patients With Acute Coronary Syndrome: The OSA-ACS Project

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
In-hospital patients with ACS and undergoing sleep study
  • Obstructive Sleep Apnea of Adult
  • Acute Coronary Syndrome
  • Other: Patients with OSA based on sleep study
    Polysomnography or Polygraphy
  • Other: Patients without OSA based on sleep study
    Polysomnography or Polygraphy
  • OSA
    Intervention: Other: Patients with OSA based on sleep study
  • Non-OSA
    Intervention: Other: Patients without OSA based on sleep study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
Same as current
January 2020
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Xiao Wang, MD 86-10-84005255 spaceeye123@126.com
China
 
 
NCT03362385
2013025
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Shao-Ping Nie, Beijing Anzhen Hospital
Beijing Anzhen Hospital
Not Provided
Not Provided
Beijing Anzhen Hospital
November 2017