CClinicalTrials.gg
Status unknownNCT00854997Updated Mar 3, 2009

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

An observational study in Sleep Apnea, Obstructive and Acute Myocardial Infarction, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-03.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Sleep Apnea, Obstructive
  • Acute Myocardial Infarction

Keywords

  • Obstructive sleep apnea; myocardial infarction
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In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's planned enrollment of 120 is above the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    AMI with OSA

  • 2

    AMI without OSA

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What researchers measure

Primary outcomes

  1. mortality rate

    Time frame: 36 months

Secondary outcomes

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

    Time frame: 36months

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    • Peilin Lee, M.D. · Contact · peilin1986@yahoo.com.tw · +886-2-23123456
    • Peilin Lee, M.D. · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00854997
Lead sponsor
National Taiwan University Hospital
First posted
Mar 3, 2009
Start date
Jan 2009
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Mar 3, 2009

Study contacts

Peilin Lee, M.D.
Contact
peilin1986@yahoo.com.tw
+886-2-23123456 ext. 3543
Peilin Lee, M.D.
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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