Coronary Artery DiseaseIDEAS-OSANCT01306526
Relationship Between Obstructive Sleep Apnea and Coronary Atherosclerosis
An observational study of Coronary Artery Disease and Obstructive Sleep Apnea, run by National University of Singapore at 1 site in Singapore.
Trial summary
Obstructive sleep apnea (OSA) is a respiratory disorder of sleep characterized by recurrent episodes of complete or partial upper airway obstruction, leading to intermittent oxygen deprivation. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Obstructive Sleep Apnea
- How many people
- 118 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2011to Mar 2013
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 21 to 80 years who are scheduled to undergo either an elective, urgent or emergent diagnostic coronary angiography are eligible
Who may be able to join
- Angiogrqaphically documented coronary artery disease
- De novo lesion
- Native coronary artery
Who cannot join
- known OSA
- intubation and mechanical ventilation
- electrical instability with a high risk of malignant ventricular arrhythmia
- cardiogenic shock
- previous coronary artery bypass surgery
- chronic renal failure on dialysis
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Health System
Singapore, Singapore, 119074
About this study
Official title: Intravascular Ultrasound Diagnostic Evaluation of Atherosclerosis in Singapore- Obstructive Sleep Apnea (IDEAS-OSA) Study
Obstructive sleep apnea (OSA) is a respiratory disorder of sleep characterized by recurrent episodes of complete or partial upper airway obstruction, leading to intermittent oxygen deprivation. This results in sympathetic activation and surges in blood pressure, production of vasoactive substances, as well as activation of the inflammatory and procoagulant pathways. Epidemiological evidence indicates the prevalence of OSA is higher in patients with coronary artery disease than in the general population. The investigators recently showed that 65.7% and 41.9% of the Singapore patients admitted with myocardial infarction were found to have previously undiagnosed OSA and severe OSA, respectively. In a 10-year follow-up epidemiological study, OSA was independently associated with a higher prevalence of fatal and non-fatal cardiovascular events among the otherwise healthy general population. The investigators further showed that in patients who have undergone primary percutaneous coronary intervention for acute myocardial infarction, OSA was an independent predictor of future adverse event rates. Despite the observed association between OSA and adverse cardiovascular outcomes, the underlying pathophysiological mechanisms remain unclear. In this proposal, the investigators aim to elucidate the relationship between OSA and composition of coronary atherosclerotic plaques.
- Conditions
- Coronary Artery Disease, Obstructive Sleep Apnea
- Keywords
- Thin-cap fibroatheroma, Vulnerable plaque, Coronary artery disease, Obstructive sleep apnea, Intravascular Ultrasound
- Medical subject headings
- Coronary Artery Disease, Sleep Apnea, Obstructive
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 |
|---|---|---|
| Moderate to Severe OSA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Atheroma Volume
Relationship between OSA and Total Atheroma Volume determined (IVUS) will be determined
Measured: Baseline
Secondary outcomes (1)
Thin-cap fibroatheroma
Relation between OSA and prevalence of thin-cap fibroatheroma (VH-IVUS) will be determined
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Hang Lee, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306526
- Sponsor's protocol ID
- DSRB: C/10/341
- Acronym
- IDEAS-OSA
- Status last verified
- Jan 2014
- First submitted
- 1 Mar 2011
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee CH, Sethi R, Li R, Ho HH, Hein T, Jim MH, Loo G, Koo CY, Gao XF, Chandra S, Yang XX, Furlan SF, Ge Z, Mundhekar A, Zhang WW, Uchoa CH, Kharwar RB, Chan PF, Chen SL, Chan MY, Richards AM, Tan HC, Ong TH, Roldan G, Tai BC, Drager LF, Zhang JJ. Obstructive Sleep Apnea and Cardiovascular Events After Percutaneous Coronary Intervention. Circulation. 2016 May 24;133(21):2008-17. doi: 10.1161/CIRCULATIONAHA.115.019392. Epub 2016 May 13.
PubMed 27178625Tan A, Hau W, Ho HH, Ghaem Maralani H, Loo G, Khoo SM, Tai BC, Richards AM, Ong P, Lee CH. OSA and coronary plaque characteristics. Chest. 2014 Feb;145(2):322-330. doi: 10.1378/chest.13-1163.
PubMed 24178625
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Diagnostic Evaluation of Atherosclerosis in Singapore- Obstructive Sleep Apnea (IDEAS-OSA) Study
- ClinicalTrials.gov ID
- NCT01306526
- Acronym / sponsor ID
- IDEAS-OSA / DSRB: C/10/341
- Conditions
- Coronary Artery Disease, Obstructive Sleep Apnea
- Keywords
- Thin-cap fibroatheroma, Vulnerable plaque, Coronary artery disease, Obstructive sleep apnea, Intravascular Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Mar 2011 (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.
Obstructive sleep apnea (OSA) is a respiratory disorder of sleep characterized by recurrent episodes of complete or partial upper airway obstruction, leading to intermittent oxygen deprivation. This results in sympathetic activation and surges in blood pressure, production of vasoactive substances, as well as activation of the inflammatory and procoagulant pathways. Epidemiological evidence indicates the prevalence of OSA is higher in patients with coronary artery disease than in the general population. The investigators recently showed that 65.7% and 41.9% of the Singapore patients admitted with myocardial infarction were found to have previously undiagnosed OSA and severe OSA, respectively. In a 10-year follow-up epidemiological study, OSA was independently associated with a higher prevalence of fatal and non-fatal cardiovascular events among the otherwise healthy general population. The investigators further showed that in patients who have undergone primary percutaneous coronary intervention for acute myocardial infarction, OSA was an independent predictor of future adverse event rates. Despite the observed association between OSA and adverse cardiovascular outcomes, the underlying pathophysiological mechanisms remain unclear. In this proposal, the investigators aim to elucidate the relationship between OSA and composition of coronary atherosclerotic plaques.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate to Severe OSA | – | – |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 21 to 80 years who are scheduled to undergo either an elective, urgent or emergent diagnostic coronary angiography are eligible
Key inclusion criteria (3 listed)
- Angiogrqaphically documented coronary artery disease
- De novo lesion
- Native coronary artery
Key exclusion criteria (7 listed)
- known OSA
- intubation and mechanical ventilation
- electrical instability with a high risk of malignant ventricular arrhythmia
- cardiogenic shock
- previous coronary artery bypass surgery
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
Total Atheroma Volume
Time frame: Baseline
Relationship between OSA and Total Atheroma Volume determined (IVUS) will be determined
1 secondary outcome
Thin-cap fibroatheroma
Time frame: Baseline
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 9 Jan 2014.
- Derived from this study: PubMed 27178625Lee CH, Sethi R, Li R, Ho HH, Hein T, Jim MH, Loo G, Koo CY, Gao XF, Chandra S, Yang XX, Furlan SF, Ge Z, Mundhekar A, Zhang WW, Uchoa CH, Kharwar RB, Chan PF, Chen SL, Chan MY, Richards AM, Tan HC, Ong TH, Roldan G, Tai BC, Drager LF, Zhang JJ. Obstructive Sleep Apnea and Cardiovascular Events After Percutaneous Coronary Intervention. Circulation. 2016 May 24;133(21):2008-17. doi: 10.1161/CIRCULATIONAHA.115.019392. Epub 2016 May 13.
- Derived from this study: PubMed 24178625Tan A, Hau W, Ho HH, Ghaem Maralani H, Loo G, Khoo SM, Tai BC, Richards AM, Ong P, Lee CH. OSA and coronary plaque characteristics. Chest. 2014 Feb;145(2):322-330. doi: 10.1378/chest.13-1163.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease and 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 3 inclusion and 7 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 9 Jan 2014. 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?
Total Atheroma Volume (time frame: Baseline). 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 NCT01306526, which also lists 2 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 9 Jan 2014; AzTrials last refreshed its copy on 31 Oct 2026.