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

June 22, 2015 updated by: Xiandao Yuan M.D., Beijing Anzhen Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 10029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: no-CPAP
CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years
EXPERIMENTAL: CPAP
CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years
Device: CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Investigators

  • Study Chair: Yongxiang Wei, MD PhD, Capital Medical University Affiliated Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

February 22, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMU-881206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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