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

Capital Medical University

Status: Unknown

Conditions: Ischaemic Heart Desease; Obstructive Sleep Apnea

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02080156

CMU-881206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,200 participants in 2 patient groups

no-CPAP

No Intervention group

Description:

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

CPAP

Experimental group

Description:

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

Treatment:

Device: CPAP