Acute Myocardial Infarction Clinical Trial
Official title:
The Impact of Obstructive Sleep Apnea on the Outcomes in Patients of First-Time Acute Myocardial Infarction
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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