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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01217346
Other study ID # UW 09-127
Secondary ID
Status Terminated
Phase N/A
First received October 4, 2010
Last updated August 1, 2013
Start date February 2009
Est. completion date December 2012

Study information

Verified date August 2013
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethic committee of the University of Hong Kong, Hospital Authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Intervention

Other:
no intervention is involved in this study
no intervention is involved in this study

Locations

Country Name City State
Hong Kong Queen Mary Hospital, The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Philip P, Guilleminault C. ST segment abnormality, angina during sleep and obstructive sleep apnea. Sleep. 1993 Sep;16(6):558-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary apnea hypopnea index 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 No
Secondary endothelial function 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 No
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