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

NCT ID: NCT02080156

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Obstructive Sleep Apnea; Ischaemic Heart Desease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

no-CPAP

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

CPAP

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

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

Interventions

CPAP

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiandao Yuan M.D.

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongxiang Wei, MD PhD

Role: STUDY_CHAIR

Capital Medical University Affiliated Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiandao Yuan, MD

Role: CONTACT

yuanxiandao@126.com

18511821308

Hao Wu, MD

Role: CONTACT

wuhao8812@126.com

18701617082

Facility Contacts

Xiandao Yuan, MD

Role: primary

yuanxiandao@126.com

18511821308

Other Identifiers

CMU-881206

Identifier Type: -

Identifier Source: org_study_id