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

Completed

• Conditions: Acute Myocardial Infarction; Obstructive Sleep Apnea

• Registration Number: NCT03600246
• Lead Sponsor: Wonju Severance Christian Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Primary Completion: 2020-06-10
• Study Completion: 2020-07-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age > 20 years
2. Successful PCI in at least one major epicedial coronary artery

Exclusion Criteria

1. IABP or other hemodynamic support device
2. Known OSA on CPAP treatment
3. Intubation for mechanical ventilation
4. Sedation given before WATCH-PAT study
5. Cardiogenic shock (SBP<90mmHg)
6. Heart failure requiring oxygen supplement
7. High risk of malignant ventricular arrhythmia
8. Pregnancy
9. History of malignancy
10. Expected life span <12 months
11. Inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of OSA (%)	1 day during sleep	Incidence rate (%) of obstructive sleep apnea

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of