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

Not Applicable

• Conditions: Ischaemic Heart Desease; Obstructive Sleep Apnea
• Interventions: Device: CPAP

• Registration Number: NCT02080156
• Lead Sponsor: Beijing Anzhen Hospital

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.

Study Timeline

• Study First Submitted: 2014-02-22
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Study Start: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-24
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP	CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years

Primary Outcome Measures

Name	Time	Method
Mortality	3 years

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China