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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 : 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
Sponsor:
Information provided by (Responsible Party):
Shao-Ping Nie, Beijing Anzhen Hospital

Tracking Information
First Submitted Date November 7, 2017
First Posted Date December 5, 2017
Last Update Posted Date December 5, 2017
Actual Study Start Date May 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 29, 2017)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 29, 2017)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population In-hospital patients with ACS and undergoing sleep study
Condition
  • Obstructive Sleep Apnea of Adult
  • Acute Coronary Syndrome
Intervention
  • Other: Patients with OSA based on sleep study
    Polysomnography or Polygraphy
  • Other: Patients without OSA based on sleep study
    Polysomnography or Polygraphy
Study Groups/Cohorts
  • OSA
    Intervention: Other: Patients with OSA based on sleep study
  • Non-OSA
    Intervention: Other: Patients without OSA based on sleep study
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 29, 2017)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03362385
Other Study ID Numbers 2013025
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Shao-Ping Nie, Beijing Anzhen Hospital
Study Sponsor Beijing Anzhen Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Beijing Anzhen Hospital
Verification Date November 2017