Prospective Observational Registry for Obstructive Sleep Apnea in Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) has been known as a risk factor for coronary artery disease, heart failure, cerebrovascular accident and atrial fibrillation. One study reported that patients with OSA have more atherosclerotic plaque burden in intravascular ultrasonography examination. Among patients who admitted with acute myocardial infarction (AMI), 65.7% (69 of 105) patients were diagnosed with OSA. Other long-term follow-up study revealed that 45.4% of patients (594 of 1311) who performed percutaneous coronary intervention (PCI) were diagnosed with OSA. Moreover, the OSA group was a significant independent predictor of major adverse cardiac and cerebrovascular events (MACCEs). Polysomnography (PSG) is the gold standard for the diagnosis of OSA. But, PSG is expensive, time-consuming and difficult to perform immediately. Recently, a portable device named WATCH-PAT (Itamar Ltd, Israel) was developed for the diagnosis of OSA. Validation study demonstrated a high correlation between WATCH-PAT and PSG in apnea-hypopnea index, lowest oxygen saturation and sleep time. This result suggested WATCH-PAT can be performed as an alternative or supportive device of PSG. WATCH-PAT. The portable device also can be useful to detect OSA in bus drivers who can be the reason for public traffic accidents. Moreover, WATCH-PAT can be applied to assess postoperative improvement of OSA. Although OSA is known as one of the risk factors for cardiovascular disease, there is a lack of evidence to recommend of the evaluation of sleep disorder in patient with coronary artery disease. Awareness and compliance for OSA are very low in both patients and cardiologists. Active diagnosis and treatment are definitely needed. Therefore, the primary endpoint of this study is to evaluate the prevalence of OSA in AMI patients who treated PCI. The secondary endpoint is to evaluate the 1-year incidence rate of MACCEs according to the presence or absence of OSA.

Official Title
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Prospective Observational Registry for Obstructive Sleep Apnea in Patients With Acute Myocardial Infarction

Conditions
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Obstructive Sleep Apnea, Acute Myocardial Infarction

Intervention / Treatment
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* Device: WATCH-PAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 20 years Successful PCI in at least one major epicedial coronary artery Exclusion Criteria: IABP or other hemodynamic support device Known OSA on CPAP treatment Intubation for mechanical ventilation Sedation given before WATCH-PAT study Cardiogenic shock (SBP<90mmHg) Heart failure requiring oxygen supplement High risk of malignant ventricular arrhythmia Pregnancy History of malignancy Expected life span <12 months Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: WATCH-PAT|WatchPAT is an FDA-approved portable diagnostic device that uniquely uses finger based physiology and innovative technology to enable simple and accurate Obstructive Sleep Apnea (OSA) testing while avoiding the complexity and discomfort associated with traditional air-flow based systems.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of OSA (%) | Incidence rate (%) of obstructive sleep apnea | 1 day during sleep | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE (%) | Incidence rate (%) of MACCE defined as composite endpoint of all-cause death, myocardial infarction, any revacularization and stroke | 1 year | 
| All-cause death (%) | Incidence rate (%) of all-cause death | 1 year | 
| Any myocardial infarction (%) | Incidence rate (%) of any myocardial infarction | 1 year | 
| Any revascularization (%) | Incidence rate (%) of any revascularization | 1 year | 
| Stroke (%) | Incidence rate (%) of stroke | 1 year |