NCT01217346

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2013

Enrollment Period

3.8 years

First QC Date

October 4, 2010

Last Update Submit

August 1, 2013

Conditions

Obstructive Sleep ApneaCardiac Syndrome XEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • endothelial function

    measured at a single time point when the subjects are admitted for overnight polysomnography

Study Arms (1)

cardiac syndrome X

subjects fulfilling the clinical triad of cardiac syndrome X

Other: no intervention is involved in this study

Interventions

no intervention is involved in this studyOTHER

no intervention is involved in this study

cardiac syndrome X

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, 852, Hong Kong

Location

Related Publications (5)

  • 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. doi: 10.1164/rccm.200306-767OC. Epub 2003 Oct 9.

    PMID: 14551167BACKGROUND

  • 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. doi: 10.1016/s0025-6196(12)61063-5.

    PMID: 8133662BACKGROUND

  • Philip P, Guilleminault C. ST segment abnormality, angina during sleep and obstructive sleep apnea. Sleep. 1993 Sep;16(6):558-9. doi: 10.1093/sleep/16.6.558. No abstract available.

    PMID: 8235241BACKGROUND

  • 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. doi: 10.1378/chest.99.4.1023.

    PMID: 2009755BACKGROUND

  • 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. doi: 10.1016/j.pcad.2007.01.003. No abstract available.

    PMID: 18156008BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMicrovascular Angina

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesAngina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Macy MS Lui

    Queen Mary Hospital, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 8, 2010

Study Start

February 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 2, 2013

Record last verified: 2013-08

Locations

HK(1)