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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02080156

Enrollment

1200

Registered

2014-03-06

Start date

2015-01-31

Completion date

2020-12-31

Last updated

2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic Heart Desease, Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft, Mortality, Questionnaire, Biomarker

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.

Interventions

DEVICECPAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Mortality	3 years

Countries

China

Contacts

Primary ContactXiandao Yuan, MD

yuanxiandao@126.com18511821308

Backup ContactHao Wu, MD

wuhao8812@126.com18701617082

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026