Obstructive Sleep ApneaNCT02215317
Sleep and Stent Study: a Multicentre, Prospective Study
An observational study of Obstructive Sleep Apnea, run by National University of Singapore at 1 site in Singapore.
Trial summary
Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is crucial in risk assessments and therapeutic recommendations for affected individuals. The Sleep and Stent Study is a multi-center observational study investigating the relationships between OSA and cardiovascular outcomes in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 1,815 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2011to Sep 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective, observational multi-national cohort study of patients undergoing PCI for coronary artery disease. Adult patients undergoing clinically indicated PCI for coronary artery disease will be enrolled in the Sleep and Stent Study.
Who may be able to join
- Age ≥18 years old and < 80 years old
- Successful PCI to at least one of the epicardial coronary arteries
Who cannot join
- Known OSA on CPAP treatment
- Intubation for mechanical ventilation
- Intra-aortic balloon pump or other hemodynamic support device
- Sedation or other muscle relaxant given before overnight sleep study
- Perceived high risk of malignant ventricular arrhythmia
- Cardiogenic shock with systolic blood pressure <90 mmHg
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- Clinical heart failure requiring oxygen supplementation
- Pregnancy
- History of malignancy (except non-melanoma skin cancer, cervical in-situ carcinoma, breast ductal carcinoma in situ or stage 1 prostate carcinoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention
Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is crucial in risk assessments and therapeutic recommendations for affected individuals. The Sleep and Stent Study is a multi-center observational study investigating the relationships between OSA and cardiovascular outcomes in patients treated with percutaneous coronary intervention (PCI).
Read the detailed description
Preliminary data suggest that OSA may lead to adverse cardiovascular outcomes after PCI. However, existing data were generated from small-scale, single-center studies. Therefore, in the Sleep and Stent Study, the investigators aim to conduct a large-scale multi-national cohort study to determine the association between OSA and the incidence of adverse cardiovascular outcomes over a long-term follow-up period. The investigators hypothesize that OSA is an independent risk factor for the development of major adverse cardiovascular and cerebrovascular events (MACCEs) in coronary artery disease patients treated with PCI. Results from the Sleep and Stent Study will advance the fundamental understanding of the burden and prognostic implications of OSA in patients undergoing PCI for coronary artery disease.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep Apnea, Stent, Coronary Artery Disease, Percutaneous Coronary Intervention
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OSA group | Patients found to have OSA based on an overnight sleep study | |
| Non-OSA group | Patients found not to have OSA based on an overnight sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)
Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization
Measured: Two years
Secondary outcomes (1)
Number of Participants with Adverse Events other than MACCE
All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startDec 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 National University of SingaporeThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,815 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Chi-Hang Lee, National University of Singapore
- Investigators
- Chi-Hang Lee, MD, Principal investigator, National University Heart Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215317
- Sponsor's protocol ID
- SSS
- Status last verified
- Feb 2017
- First submitted
- 8 Aug 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Loo G, Koo CY, Zhang J, Li R, Sethi R, Ong TH, Tai BC, Lee CH. Impact of obstructive sleep apnea on cardiovascular outcomes in patients treated with percutaneous coronary intervention: rationale and design of the sleep and stent study. Clin Cardiol. 2014 May;37(5):261-9. doi: 10.1002/clc.22261.
PubMed 24945037
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02215317
- Acronym / sponsor ID
- SSS
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep Apnea, Stent, Coronary Artery Disease, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,815 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Dec 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Aug 2014 (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.
Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is crucial in risk assessments and therapeutic recommendations for affected individuals. The Sleep and Stent Study is a multi-center observational study investigating the relationships between OSA and cardiovascular outcomes in patients treated with percutaneous coronary intervention (PCI).
Detailed description
Preliminary data suggest that OSA may lead to adverse cardiovascular outcomes after PCI. However, existing data were generated from small-scale, single-center studies. Therefore, in the Sleep and Stent Study, the investigators aim to conduct a large-scale multi-national cohort study to determine the association between OSA and the incidence of adverse cardiovascular outcomes over a long-term follow-up period. The investigators hypothesize that OSA is an independent risk factor for the development of major adverse cardiovascular and cerebrovascular events (MACCEs) in coronary artery disease patients treated with PCI. Results from the Sleep and Stent Study will advance the fundamental understanding of the burden and prognostic implications of OSA in patients undergoing PCI for coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA group | – | –Patients found to have OSA based on an overnight sleep study |
| Non-OSA group | – | –Patients found not to have OSA based on an overnight sleep study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, observational multi-national cohort study of patients undergoing PCI for coronary artery disease. Adult patients undergoing clinically indicated PCI for coronary artery disease will be enrolled in the Sleep and Stent Study.
Key inclusion criteria (2 listed)
- Age ≥18 years old and < 80 years old
- Successful PCI to at least one of the epicardial coronary arteries
Key exclusion criteria (9 listed)
- Known OSA on CPAP treatment
- Intubation for mechanical ventilation
- Intra-aortic balloon pump or other hemodynamic support device
- Sedation or other muscle relaxant given before overnight sleep study
- Perceived high risk of malignant ventricular arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)
Time frame: Two years
Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization
1 secondary outcome
Number of Participants with Adverse Events other than MACCE
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 24945037Loo G, Koo CY, Zhang J, Li R, Sethi R, Ong TH, Tai BC, Lee CH. Impact of obstructive sleep apnea on cardiovascular outcomes in patients treated with percutaneous coronary intervention: rationale and design of the sleep and stent study. Clin Cardiol. 2014 May;37(5):261-9. doi: 10.1002/clc.22261.
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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.
Chi-Hang Lee, MD principal investigator
National University Heart Centre, Singapore
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, run by National University of Singapore at 1 site in Singapore.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 23 Feb 2017. 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 Singapore. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE) (time frame: Two years). 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 NCT02215317, which also lists 1 linked publication.
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 23 Feb 2017.