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

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ClinicalTrials.gov Identifier: NCT01217346
Recruitment Status : Terminated
First Posted : October 8, 2010
Last Update Posted : August 2, 2013
Sponsor:
Information provided by:
The University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Cardiac Syndrome X Endothelial Dysfunction Other: no intervention is involved in this study

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Study Start Date : February 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with chest pain, positive exercise treadmill test and normal coronary angiogram
Criteria

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)

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): NCT01217346


Locations
Hong Kong
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, 852
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Macy MS Lui Queen Mary Hospital, The University of Hong Kong

Publications:
Responsible Party: Lui Mei Sze Macy, Queen Mary Hospital, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01217346     History of Changes
Other Study ID Numbers: UW 09-127
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Microvascular Angina
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases