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

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ClinicalTrials.gov Identifier: NCT02080156
Recruitment Status : Unknown
Verified June 2015 by Xiandao Yuan M.D., Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : March 6, 2014
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Xiandao Yuan M.D., Beijing Anzhen Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Ischaemic Heart Desease Device: CPAP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Continuous Positive Airway Pressure Therapy on Outcomes in Patients Undergoing Coronary Revascularization
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080156


Contacts
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Contact: Xiandao Yuan, MD 18511821308 yuanxiandao@126.com
Contact: Hao Wu, MD 18701617082 wuhao8812@126.com

Locations
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China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 10029
Contact: Xiandao Yuan, MD    18511821308    yuanxiandao@126.com   
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
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Study Chair: Yongxiang Wei, MD PhD Capital Medical University Affiliated Beijing Anzhen Hospital
More Information
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Responsible Party: Xiandao Yuan M.D., MD, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02080156    
Other Study ID Numbers: CMU-881206
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Keywords provided by Xiandao Yuan M.D., Beijing Anzhen Hospital:
Obstructive Sleep Apnea
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft
 Mortality
Questionnaire
Biomarker
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases