Obstructive Sleep ApneaNCT01217346
A Prevalence Study of Obstructive Sleep Apnea in Subjects With Chest Pain, Positive Exercise Treadmill Test and Normal Coronary Angiogram
An observational study of Obstructive Sleep Apnea and Cardiac Syndrome X, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Cardiac Syndrome X, Endothelial Dysfunction
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with chest pain, positive exercise treadmill test and normal coronary angiogram
Who may be able to join
- 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
Who cannot join
- Mentally incapacitated persons
- Congestive heart failure
- Other potential causes of orthopnea (severe chronic obstructive pulmonary disease, persistent asthma)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Queen Mary Hospital, The University of Hong Kong
Hong Kong, 852
About this study
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.
- Being tested
- no intervention is involved in this study
- Medical subject headings
- Sleep Apnea, Obstructive, Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention is involved in this studyOther
no intervention is involved in this study
| Study group | Role | What they receive |
|---|---|---|
| cardiac syndrome X | subjects fulfilling the clinical triad of cardiac syndrome X Receives: Other: no intervention is involved in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea hypopnea index
assess apnea hypopnea index by overnight polysomnography, by a single admission to sleep laboratory
Measured: measure at a single time point when the subjects are admitted for overnight polysomnography
Secondary outcomes (1)
endothelial function
assess endothelial function by EndoPAT 2000 (an non-invasive device) and peripheral blood endothelial progenitor cells
Measured: measured at a single time point when the subjects are admitted for overnight polysomnography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Macy MS Lui, Principal investigator, Queen Mary Hospital, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217346
- Sponsor's protocol ID
- UW 09-127
- Status last verified
- Aug 2013
- First submitted
- 4 Oct 2010
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1164/rccm.200306-767OC. Epub 2003 Oct 9.
PubMed 14551167Loui 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.
PubMed 8133662Philip 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.
PubMed 8235241Chan 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.
PubMed 2009755Melikian 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.
PubMed 18156008
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prevalence Study of Obstructive Sleep Apnea in Subjects With Chest Pain, Positive Exercise Treadmill Test and Normal Coronary Angiogram
- ClinicalTrials.gov ID
- NCT01217346
- Acronym / sponsor ID
- UW 09-127
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac syndrome X | – | Other: no intervention is involved in this studysubjects fulfilling the clinical triad of cardiac syndrome X |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chest pain, positive exercise treadmill test and normal coronary angiogram
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Mentally incapacitated persons
- Congestive heart failure
- Other potential causes of orthopnea (severe chronic obstructive pulmonary disease, persistent asthma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention is involved in this studyno intervention is involved in this study | Other | cardiac syndrome X |
Primary outcome
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
1 secondary outcome
endothelial function
Time frame: measured at a single time point when the subjects are admitted for overnight polysomnography
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Background: PubMed 14551167Ip 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.
- Background: PubMed 8133662Loui 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.
- Background: PubMed 8235241Philip 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.
- Background: PubMed 2009755Chan 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.
- Background: PubMed 18156008Melikian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Macy MS Lui principal investigator
Queen Mary Hospital, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Cardiac Syndrome X, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea hypopnea index (time frame: measure at a single time point when the subjects are admitted for overnight polysomnography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217346, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.