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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2010 by The University of Hong Kong.
Recruitment status was Recruiting

Sponsor:

Information provided by:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT01217346

First received: October 4, 2010

Last updated: October 7, 2010

Last verified: October 2010

History of Changes

Purpose

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	Intervention
Obstructive Sleep Apnea Cardiac Syndrome X Endothelial Dysfunction	Other: no intervention is involved in this study

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain Exercise and Physical Fitness Sleep Apnea

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:

apnea hypopnea index [ Time Frame: measure at a single time point when the subjects are admitted for overnight polysomnography ] [ Designated as safety issue: No ]
assess apnea hypopnea index by overnight polysomnography, by a single admission to sleep laboratory

Secondary Outcome Measures:

endothelial function [ Time Frame: measured at a single time point when the subjects are admitted for overnight polysomnography ] [ Designated as safety issue: No ]
assess endothelial function by EndoPAT 2000 (an non-invasive device) and peripheral blood endothelial progenitor cells

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217346

Contacts

Contact: Macy MS Lui, MBBS, MRCP

852-22554455

macylui@graduate.hku.hk

Locations

Hong Kong
Queen Mary Hospital, The University of Hong Kong	Recruiting
Hong Kong, Hong Kong, 852
Contact: Macy MS Lui, MBBS, MRCP 852-22554455 macylui@graduate.hku.hk
Sub-Investigator: David CW Siu, MBBS
Sub-Investigator: Mary SM Ip, MD

Sponsors and Collaborators

The University of Hong Kong

Investigators

Principal Investigator:

Macy MS Lui

Queen Mary Hospital, The University of Hong Kong

More Information

Publications:

Ip MS, Tse HF, Lam B, Tsang KW, Lam WK. Endothelial function in obstructive sleep apnea and response to treatment. Am J Respir Crit Care Med. 2004 Feb 1;169(3):348-53. Epub 2003 Oct 9.

Loui WS, Blackshear JL, Fredrickson PA, Kaplan J. Obstructive sleep apnea manifesting as suspected angina: report of three cases. Mayo Clin Proc. 1994 Mar;69(3):244-8. Review.

Philip P, Guilleminault C. ST segment abnormality, angina during sleep and obstructive sleep apnea. Sleep. 1993 Sep;16(6):558-9. No abstract available.

Chan HS, Chiu HF, Tse LK, Woo KS. Obstructive sleep apnea presenting with nocturnal angina, heart failure, and near-miss sudden death. Chest. 1991 Apr;99(4):1023-5.

Melikian N, De Bruyne B, Fearon WF, MacCarthy PA. The pathophysiology and clinical course of the normal coronary angina syndrome (cardiac syndrome X). Prog Cardiovasc Dis. 2008 Jan-Feb;50(4):294-310. Review. No abstract available.

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
Study First Received:	October 4, 2010
Last Updated:	October 7, 2010
Health Authority:	Hong Kong: Ethic committee of the University of Hong Kong, Hospital Authority

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Microvascular Angina
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic

Dyssomnias
Sleep Disorders
Nervous System Diseases
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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