NCT02080156

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea
• Ischaemic Heart Desease

Interventions

Type	Name	Description
DEVICE	CPAP

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-12-01
• Completion: 2020-12-01
• First posted: 2014-03-06
• Last updated: 2015-06-24

Locations

1 site across 1 country: China