NCT02080156

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

3.9 years

First QC Date

February 22, 2014

Last Update Submit

June 22, 2015

Conditions

Obstructive Sleep ApneaIschaemic Heart Desease

Keywords

Obstructive Sleep ApneaPercutaneous Coronary InterventionCoronary Artery Bypass GraftMortalityQuestionnaireBiomarker

Outcome Measures

Primary Outcomes (1)

  • Mortality

    3 years

Study Arms (2)

no-CPAP

NO INTERVENTION

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

CPAP

EXPERIMENTAL

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

Device: CPAP

Interventions

CPAPDEVICE
CPAP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • OSA patients who has already started treatment
  • Patients presenting mainly central apnea (≥ 50%)
  • Respiratory insufficiency patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 10029, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Yongxiang Wei, MD PhD

    Capital Medical University Affiliated Beijing Anzhen Hospital

    STUDY CHAIR

Central Study Contacts

Xiandao Yuan, MD

CONTACT

18511821308yuanxiandao@126.com

Hao Wu, MD

CONTACT

18701617082wuhao8812@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 22, 2014

First Posted

March 6, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

CN(1)