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Sleep Apnea, ObstructiveNCT00854997

The Impact of Obstructive Sleep Apnea on the Outcomes in Patients of First-Time Acute Myocardial Infarction

An observational study of Sleep Apnea, Obstructive and Acute Myocardial Infarction, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective: Untreated OSA is associated with three fold risk of fetal and non-fetal cardiovascular events than control subjects in the long-term follow up. However, the prevalence rate and impact of OSA in patients with acute myocardial infarction (AMI) was not clear so far. Read more about this study

Who is it for?
Ages 18 years and older
How many people
120 participants
Where
1 siteTaiwan
Study dates
Jan 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: first-time, Killip I-II, post primary PCI within 5th -7th day of AMI

Who may be able to join

  • first-time, Killip I-II, post primary PCI within 5th -7th day of AMI

Who cannot join

  • refuse to participate, require mechanical ventilation, active neurologic event, chronic pulmonary disease, active infection, need sedatives or narcotics within 3 days of sleep study, and participate in other study at the same time

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    Peilin Lee, M.D., +886-2-23123456 ext. 3543, peilin1986@yahoo.com.tw

    Peilin Lee, M.D.

    Recruiting

Other trials in Taiwan

About this study

Objective: Untreated OSA is associated with three fold risk of fetal and non-fetal cardiovascular events than control subjects in the long-term follow up. However, the prevalence rate and impact of OSA in patients with acute myocardial infarction (AMI) was not clear so far. The conflicts of studies come from variable period of AMI, heart function at enrollment, techniques used to diagnose OSA, time to revascularization, and target endpoint. Therefore, this project aimed to study the patients of first-time, Killip I-II, and post primary percutaneous coronary intervention (PCI) AMI in both and chronic phase to achieve four goals:

Aim 1. To determine the prevalence rate of OSA in patients with first-time AMI The acute phase of AMI was defined as within 14 days of the onset of AMI and the chronic phase was defined as > 14 days of onset. Eligible patients were screened with polysomnography within 5th to 7th days and 6th months of AMI to determine the prevalence rate of OSA in the AMI. Patients who had AHI more than 15/hr were considered as suffering from OSA.

Read more

Aim 2. To identify the clinical characteristics and risk factors in AMI patients associated with OSA Patients were followed up at clinics for five years. The baseline demographics of patients with or without OSA were compared to determine the factors associated with OSA in AMI patients.

Aim 3. To study the impact of OSA on the prognosis of AMI patients after revascularizaton The primary endpoint was mortality rate and cardiac events. The secondary endpoint was left ventricular function and variables related to cardiovascular disease (CVD) and metabolic syndrome. The impact of OSA on AMI was determined by comparing primary and secondary endpoint between AMI patients with and without OSA.

Aim 4. To identify the clinical and molecular factors attributing to AMI in OSA patients Factors attributing to AMI in OSA patients were determined by comparing the clinical data and mRNA expression of angiogenesis and other related genes in OSA patients with the acute phase of AMI and patients without major CVD.

Read the detailed description

Objectives: Obstructive sleep apnea (OSA) affects 4% middle-aged men and 2% women. Symptoms of OSA include snore, unrefresh sleep, witnessed apnea, excessive daytime sleepiness and hypertension. Untreated OSA patients are associated with three fold risk of fetal and non-fetal cardiovascular events than control subjects. However, the prevalence rate and impact of OSA in patients with acute myocardial infarction (AMI) was not clear so far. The conflicts of studies come from variable period of AMI, heart function at enrollment, techniques used to diagnose OSA, time to revascularization, and target endpoint. Therefore, this project aimed to achieve the four goals: (1) To determine the prevalence rate of OSA in patients with first-time AMI (2) To identify the clinical characteristics and risk factors in AMI patients associated with OSA (3) To study the impact of OSA on the prognosis of AMI patients after revascularization (4) To identify the clinical and molecular factors attributing to AMI in OSA patients Study design: Longitudinal, observational study Participants: AMI patients who were first-time, Killip I-II, post primary percutaneous coronary intervention (PCI) were eligible for this study. Exclusion criteria included: refuse to participate, require mechanical ventilation, active neurologic event, chronic pulmonary disease, active infection, need sedatives or narcotics within 3 days of sleep study, and participate in other study at the same time.

Protocol: Eligible patients were screened with polysomnography (PSG) within 5th to 7th days after onset of AMI. Patients who had AHI more than 15/hr were considered as suffering from OSA. Patients were followed up for five years. The primary endpoint was mortality rate and cardiac events. The secondary endpoint was left ventricular function and variables related to cardiovascular disease (CVD) and metabolic syndrome. The acute phase of AMI was defined as within 14 days of the onset of AMI and the chronic phase was defined as > 14 days of onset.

Statistic: The baseline demographics of patients with or without OSA were compared to determine the factors associated with OSA in AMI patients. The impact of OSA on AMI in acute and chronic phase was determined by comparing the mortality rate, incidences of cardiac events, left ventricular function, CVD risk factors, and metabolic profiles between AMI patients with and without OSA. Factors attributing to AMI in OSA patients were determined by comparing the clinical data and mRNA expression of angiogenesis and other related genes in OSA patients with the acute phase of AMI and patients without major CVD.

Clinical implication: Because the prevalence rate of OSA in patients of first-time AMI but no significant heart failure was extremely high, early PSG screening and identifying factors associated with OSA will allow for early diagnosis and intervention. Understanding interaction between OSA and AMI will help prevent the morbidity and mortality in AMI patients. Also, it allows for prediction of cardiovascular outcomes and early management in OSA patients.

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.

Study groups in NCT00854997
Study groupRoleWhat they receive
1AMI with OSA
2AMI without OSA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality rate

    Measured: 36 months

Secondary outcomes (1)
  1. left ventricular function and variables related to cardiovascular disease (CVD) and metabolic syndrome.

    Measured: 36months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00854997
Sponsor's protocol ID
200812080R
Status last verified
Feb 2009
First submitted
12 Jan 2009
Last updated
3 Mar 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 2009. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peilin Lee, M.D. (+886-2-23123456 ext. 3543, peilin1986@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality rate (time frame: 36 months). 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 3 Mar 2009.

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