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Clinical Trials/NCT02080156
NCT02080156
Unknown
Not Applicable

Impact of Continuous Positive Airway Pressure Therapy on Outcomes in Patients Undergoing Coronary Revascularization

Beijing Anzhen Hospital1 site in 1 country1,200 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Beijing Anzhen Hospital
Enrollment
1200
Locations
1
Primary Endpoint
Mortality
Last Updated
10 years ago

Overview

Brief Summary

Investigators assume that continuous positive airway pressure (CPAP) therapy can reduce the mortality, stroke rate and secondary coronary surgery in CAD with obstructive sleep apnea (OSA) patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABA) during postoperative follow-up of 3 years.

Detailed Description

Investigators observe whether continuous positive airway pressure (CPAP) therapy can reduce the mortality, stroke rate and secondary coronary surgery in CAD with OSA patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABA) during postoperative follow-up of 3 years. During the 3 years, we randomize all enrolled patients to 2 groups separately beginning CPAP or no-CPAP intervention after sleep monitoring. Guidance for all patients during follow-up 1 week, 2 week, 1 month, 3 month. The follow-up procedure includes clinical assessments at three months, six months, one year, two and three years respectively.The primary outcome variables are prospectively being documented and are not subject to observer bias.Baseline comorbidity data, results of the sleep recordings, compliance with CPAP device, scores of the questionnaires as well as results of the blood analysis are performed and/or documented consecutively in separate files by research personnel blinded to the allocation of the study groups and/or unaware of the results of the concomitant outcomes.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2020
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Anzhen Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xiandao Yuan M.D.

MD

Beijing Anzhen Hospital

Eligibility Criteria

Inclusion Criteria

  • Angiography confirmed coronary heart disease (CHD) patients
  • Underwent PCI or coronary artery bypass graft (CABG) in recent the week
  • Signed informed consent
  • Mild-to-moderate OSA(5≤AHI≤100)

Exclusion Criteria

  • OSA patients who has already started treatment
  • Patients presenting mainly central apnea (≥ 50%)
  • Respiratory insufficiency patients

Outcomes

Primary Outcomes

Mortality

Time Frame: 3 years

Study Sites (1)

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