Sleep Apnea, ObstructiveNCT00821210
Obstructive Sleep Apnea and Acute Myocardial Infarction and the Role of Continuous Positive Airway Pressure (CPAP)Treatment
A study testing CPAP of optimal pressure in people with Sleep Apnea, Obstructive and Acute Myocardial Infarction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Specific Aim 1. To determine the prevalence of OSA in patients of first-time AMI in acute phase By screening patients of first-time, single-vessel disease, Killip I AMI, and successful revascularization 2. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sleep Apnea, Obstructive, Acute Myocardial Infarction
- What is being tested?
- CPAP of optimal pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Nov 2010
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time AMI
- s/p revascularization (successful primary PTCA for ischemia-related artery)
- Killip I
Who cannot join
- Refuse to participate
- Require mechanical ventilation
- Having active neurologic event, severe obstructive airway disease and active infection, active malignancy
- Need sedative drug or narcotics during the study period within 3 days of PSG
- Participates other study at the same time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstructive Sleep Apnea and Acute Myocardial Infarction and the Role of CPAP Treatment: a Double -Blind, Randomized Control Trial
Specific Aim
- To determine the prevalence of OSA in patients of first-time AMI in acute phase By screening patients of first-time, single-vessel disease, Killip I AMI, and successful revascularization
- To determine the impact of CPAP treatment on the prognosis of AMI Using sham CPAP as the optimal placebo, we conduct this randomized, double-blind, placebo controlled trial to assess the 12-week CPAP effect in moderate-severe OSA patients.
- To determine how the OSA affects patients with MI in acute and chronic phase and vice versa, which is dissected from mechanical basis and molecular basis By comparing the clinical parameters of AMI patients without OSA (AHI<5/hr), mild OSA (5 < AHI <15), moderate OSA (15<AHI<30) and severe OSA5 (AHI>30/hr), and before and after CPAP treatment, we can determine the interaction between OSA and AMI.
Read the detailed description
Obstructive sleep apnea (OSA) is a major public health problem affecting at least 2-4% of middle-aged population. OSA resulted in hypoxia and sleep fragmentation, which resulted in neurocognitive dysfunction and cardiovascular sequelaes. The cardiovascular sequelaes in OSA included hypertension, coronary artery disease and heart failure. Our data showed among 599 moderate-sever OSA (AHI<15/hr)， 44.5% patients had cardiovascular disease, which included 41.4% having hypertension，7% having CAD and 2.4% having congestive heart failure。 Though OSA is well known to be highly correlated with fatal and non-fatal cardiac event, only limited studies investigated how OSA affected acute myocardial infarction (AMI). Most studies concluded that AMI would worsen OSA and vice versa. However, how AMI exactly interacts with OSA and what the prevalence of OSA in the first-time AMI is have never been answered. Within four weeks from Nov. 15th 2007, we screened ten patients of first-time AMI with single-vessel disease and Killip I. Five in 10 received PSG and three in five have moderate OSA.
So far, CPAP is the standard treatment for patients with moderate to severe OSA. CPAP could improve airway patency, daytime sleepiness, functional status, blood pressure, metabolic abnormalities and quality of life. In our study, we enrolled 24 non-sleepy OSA and 30 sleepy OSA to study the four-week CPAP effect. The results showed the apnea-hypopnea index, hypoxia, arousal, sleepiness and fatigue could be corrected with CPAP treatment in both groups. However, CPAP could only lower risk factors for cardiovascular disease, like blood pressure, epinephrine, norepinephrine and CRP, in sleepy OSA. Our finding supported that CPAP effect was not similar in the subgroups of severe OSA, so CPAP effect should be studied in every subgroup of OSA patients before it's applied. Till now, there's no literatures reported if CPAP treatment would decrease the morbidity and mortality of AMI.
Sham CPAP mimicked all the characteristics of a true CPAP except for the null pressure, which was recently used as the placebo to study CPAP effect. Therefore, using this optimized placebo, we propose this double-blind, control randomized trial (1) To determine the prevalence of OSA in patients of first-time AMI in acute phase; (2) To determine the impact of CPAP treatment on the prognosis of AMI; (3) Determine how the OSA affects patients with MI in acute and chronic phase and vice versa, which is dissected from mechanical basis and molecular basis.
- Being tested
- Sham CPAP, CPAP of optimal pressure
- Keywords
- Obstructive sleep apnea, myocardial infarction
- Medical subject headings
- Sleep Apnea, Obstructive, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham CPAPDevice
CPAP with pressure of 3cm H2O
CPAP of optimal pressureDevice
CPAP of optimal pressure
| Study group | Role | What they receive |
|---|---|---|
| 2 | Sham comparator | Not described Receives: Device: Sham CPAP |
| 1 | Active comparator | Not described Receives: Device: CPAP of optimal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary goal: Intervention: Improvement of LVEF by 7%, decrease the left ventricular end-systolic dimension by 3 mm, 3D echo.
Measured: 12 weeks
Secondary outcomes (1)
incidence of stroke and fetal, non-fetal cardiac event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chong-Jen Yu, M.D., Principal investigator, National Taiwan University HospitalPeilin Lee, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821210
- Sponsor's protocol ID
- 200712052R
- Status last verified
- Nov 2010
- First submitted
- 12 Jan 2009
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea and Acute Myocardial Infarction and the Role of CPAP Treatment: a Double -Blind, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00821210
- Acronym / sponsor ID
- 200712052R
- Keywords
- Obstructive sleep apnea, myocardial infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Jan 2009 (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.
Specific Aim
- To determine the prevalence of OSA in patients of first-time AMI in acute phase By screening patients of first-time, single-vessel disease, Killip I AMI, and successful revascularization
- To determine the impact of CPAP treatment on the prognosis of AMI Using sham CPAP as the optimal placebo, we conduct this randomized, double-blind, placebo controlled trial to assess the 12-week CPAP effect in moderate-severe OSA patients.
- To determine how the OSA affects patients with MI in acute and chronic phase and vice versa, which is dissected from mechanical basis and molecular basis By comparing the clinical parameters of AMI patients without OSA (AHI<5/hr), mild OSA (5 < AHI <15), moderate OSA (15<AHI<30) and severe OSA5 (AHI>30/hr), and before and after CPAP treatment, we can determine the interaction between OSA and AMI.
Detailed description
Obstructive sleep apnea (OSA) is a major public health problem affecting at least 2-4% of middle-aged population. OSA resulted in hypoxia and sleep fragmentation, which resulted in neurocognitive dysfunction and cardiovascular sequelaes. The cardiovascular sequelaes in OSA included hypertension, coronary artery disease and heart failure. Our data showed among 599 moderate-sever OSA (AHI<15/hr)， 44.5% patients had cardiovascular disease, which included 41.4% having hypertension，7% having CAD and 2.4% having congestive heart failure。 Though OSA is well known to be highly correlated with fatal and non-fatal cardiac event, only limited studies investigated how OSA affected acute myocardial infarction (AMI). Most studies concluded that AMI would worsen OSA and vice versa. However, how AMI exactly interacts with OSA and what the prevalence of OSA in the first-time AMI is have never been answered. Within four weeks from Nov. 15th 2007, we screened ten patients of first-time AMI with single-vessel disease and Killip I. Five in 10 received PSG and three in five have moderate OSA.
So far, CPAP is the standard treatment for patients with moderate to severe OSA. CPAP could improve airway patency, daytime sleepiness, functional status, blood pressure, metabolic abnormalities and quality of life. In our study, we enrolled 24 non-sleepy OSA and 30 sleepy OSA to study the four-week CPAP effect. The results showed the apnea-hypopnea index, hypoxia, arousal, sleepiness and fatigue could be corrected with CPAP treatment in both groups. However, CPAP could only lower risk factors for cardiovascular disease, like blood pressure, epinephrine, norepinephrine and CRP, in sleepy OSA. Our finding supported that CPAP effect was not similar in the subgroups of severe OSA, so CPAP effect should be studied in every subgroup of OSA patients before it's applied. Till now, there's no literatures reported if CPAP treatment would decrease the morbidity and mortality of AMI.
Sham CPAP mimicked all the characteristics of a true CPAP except for the null pressure, which was recently used as the placebo to study CPAP effect. Therefore, using this optimized placebo, we propose this double-blind, control randomized trial (1) To determine the prevalence of OSA in patients of first-time AMI in acute phase; (2) To determine the impact of CPAP treatment on the prognosis of AMI; (3) Determine how the OSA affects patients with MI in acute and chronic phase and vice versa, which is dissected from mechanical basis and molecular basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Sham comparator | Device: Sham CPAP |
| 1 | Active comparator | Device: CPAP of optimal pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First-time AMI
- s/p revascularization (successful primary PTCA for ischemia-related artery)
- Killip I
Key exclusion criteria (5 listed)
- Refuse to participate
- Require mechanical ventilation
- Having active neurologic event, severe obstructive airway disease and active infection, active malignancy
- Need sedative drug or narcotics during the study period within 3 days of PSG
- Participates other study at the same time
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 |
|---|---|---|
| Sham CPAPCPAP with pressure of 3cm H2O | Device | 2 |
| CPAP of optimal pressureCPAP of optimal pressure | Device | 1 |
Primary outcome
Primary goal: Intervention: Improvement of LVEF by 7%, decrease the left ventricular end-systolic dimension by 3 mm, 3D echo.
Time frame: 12 weeks
1 secondary outcome
incidence of stroke and fetal, non-fetal cardiac event
Time frame: 12 months
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 1 Dec 2010.
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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.
Chong-Jen Yu, M.D. principal investigator
National Taiwan University Hospital
Peilin Lee, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP of optimal pressure in people with Sleep Apnea, Obstructive and Acute Myocardial Infarction, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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 1 Dec 2010. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Primary goal: Intervention: Improvement of LVEF by 7%, decrease the left ventricular end-systolic dimension by 3 mm, 3D echo. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2010.