NCT02701504

Brief Summary

Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous studies suggested sleep apnea was associated with coronary plaque burden and future adverse cardiovascular events after percutaneous coronary intervention. In the SABOT study, the investigators used a FDA-approved portable sleep device to diagnose sleep apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after non-urgent coronary artery bypass surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

5.5 years

First QC Date

September 23, 2014

Last Update Submit

March 25, 2020

Conditions

Sleep Apnea

Keywords

sleep apneacoronary artery bypass graftingoutcomes

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac and Cerebrovascular Events

    The number of patients with cardiac mortality, stroke, myocardial infarction, or repeat revascularization

    Average of 2 years after CABG

Secondary Outcomes (1)

  • Other Cardiac and Cerebrovascular Events

    Average of 2 years after CABG

Study Arms (2)

Sleep apnea group

The patients who are found to have sleep apnea based on the results of the portable sleep study

Non sleep apnea group

The patients who are found to have no sleep apnea based on the results of the portable sleep study

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with coronary artery disease scheduled to undergo coronary artery bypass surgery

You may qualify if:

  • Patients with coronary artery disease scheduled to undergo non-urgent coronary artery bypass surgery

You may not qualify if:

  • Known sleep apnea on CPAP therapy
  • Cardiogenic shock on mechanical hemodynamic support
  • Intubated on mechanical ventilation
  • Heart failure on oxygen therapy
  • Long -term alpha blocker therapy
  • Severe chronic pulmonary disease
  • Recurrent malignant arrhythmia
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Heart Centre, Singapore

Singapore, 119228, Singapore

Location

Related Publications (3)

  • Teo YH, Yong CL, Ou YH, Tam WW, Teo YN, Koo CY, Kojodjojo P, Lee CH. Obstructive sleep apnea and temporal changes in cardiac repolarization in patients undergoing coronary artery bypass grafting. J Clin Sleep Med. 2024 Jan 1;20(1):49-55. doi: 10.5664/jcsm.10786.

    PMID: 38163943DERIVED

  • Aung AT, Koo CY, Tam WW, Chen Z, Kristanto W, Sim HW, Kojodjojo P, Kofidis T, Lee CH. Sleep apnea and diabetes mellitus are independently associated with cardiovascular events and hospitalization for heart failure after coronary artery bypass grafting. Sci Rep. 2020 Dec 10;10(1):21664. doi: 10.1038/s41598-020-78700-9.

    PMID: 33303900DERIVED

  • Koo CY, Aung AT, Chen Z, Kristanto W, Sim HW, Tam WW, Gochuico CF, Tan KA, Kang GS, Sorokin V, Ong PJL, Kojodjojo P, Richards AM, Tan HC, Kofidis T, Lee CH. Sleep apnoea and cardiovascular outcomes after coronary artery bypass grafting. Heart. 2020 Oct;106(19):1495-1502. doi: 10.1136/heartjnl-2019-316118. Epub 2020 May 18.

    PMID: 32423904DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Chi-Hang Lee, MD

    National University of Singapore

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 23, 2014

First Posted

March 8, 2016

Study Start

October 1, 2013

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)