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

Obstructive Sleep Apnea Clinical Trial

— OSAAMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600246
• Other study ID #: WATCHPAT-AMI
• Status: Completed
• Start date: June 11, 2018
• Est. completion date: July 29, 2020

Study information

• Verified date: October 2020
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 29, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Apnea
• Infarction
• Myocardial Infarction
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of OSA (%)	Incidence rate (%) of obstructive sleep apnea	1 day during sleep
Secondary	MACCE (%)	Incidence rate (%) of MACCE defined as composite endpoint of all-cause death, myocardial infarction, any revacularization and stroke	1 year
Secondary	All-cause death (%)	Incidence rate (%) of all-cause death	1 year
Secondary	Any myocardial infarction (%)	Incidence rate (%) of any myocardial infarction	1 year
Secondary	Any revascularization (%)	Incidence rate (%) of any revascularization	1 year
Secondary	Stroke (%)	Incidence rate (%) of stroke	1 year