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
Recruitment status was Recruiting
Sponsor:
The University of Hong Kong
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 4, 2010 | ||||
| Last Updated Date | October 7, 2010 | ||||
| Start Date ICMJE | February 2009 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01217346 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Prevalence Study of Obstructive Sleep Apnea in Subjects With Chest Pain, Positive Exercise Treadmill Test and Normal Coronary Angiogram | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects with chest pain, positive exercise treadmill test and normal coronary angiogram |
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| Condition ICMJE |
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| Intervention ICMJE | Other: no intervention is involved in this study
no intervention is involved in this study |
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| Study Group/Cohort (s) | cardiac syndrome X
subjects fulfilling the clinical triad of cardiac syndrome X
Intervention: Other: no intervention is involved in this study |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Hong Kong | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01217346 | ||||
| Other Study ID Numbers ICMJE | UW 09-127 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lui Mei Sze Macy, Queen Mary Hospital, The University of Hong Kong | ||||
| Study Sponsor ICMJE | The University of Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Hong Kong | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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