A Prevalence Study of Obstructive Sleep Apnea in Subjects With Chest Pain, Positive Exercise Treadmill Test and Normal Coronary Angiogram

August 1, 2013 updated by: The University of Hong Kong
Cardiac syndrome X consists of a triad of chest pain, abnormal exercise stress testing and normal coronary angiogram, and is hypothesized to be related to endothelial dysfunction. Endothelial dysfunction is also reported to be linked to obstructive sleep apnea. While chest pain can be one of potential presenting symptoms of obstructive sleep apnea, the investigators hypothesize that obstructive sleep apnea is common in subjects with cardiac syndrome X.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Queen Mary Hospital, The University of Hong Kong

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with chest pain, positive exercise treadmill test and normal coronary angiogram

Description

Inclusion Criteria:

  • Age ≧18 years, < 70 years
  • Symptom of chest pain occurring at least once in the preceding year
  • Positive exercise treadmill test
  • Negative coronary angiogram
  • Mentally fit to give informed consent

Exclusion Criteria:

  • Mentally incapacitated persons
  • Congestive heart failure
  • Other potential causes of orthopnea (severe chronic obstructive pulmonary disease, persistent asthma)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cardiac syndrome X
subjects fulfilling the clinical triad of cardiac syndrome X
Other: no intervention is involved in this study
no intervention is involved in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apnea hypopnea index
Time Frame: measure at a single time point when the subjects are admitted for overnight polysomnography
assess apnea hypopnea index by overnight polysomnography, by a single admission to sleep laboratory
measure at a single time point when the subjects are admitted for overnight polysomnography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial function
Time Frame: measured at a single time point when the subjects are admitted for overnight polysomnography
assess endothelial function by EndoPAT 2000 (an non-invasive device) and peripheral blood endothelial progenitor cells
measured at a single time point when the subjects are admitted for overnight polysomnography

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Macy MS Lui, Queen Mary Hospital, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 09-127

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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