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

NCT ID: NCT03600246

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2020-07-29

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.

Conditions

Obstructive Sleep Apnea; Acute Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun-Won Lee

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun-Won Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

Locations

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

Other Identifiers

WATCHPAT-AMI

Identifier Type: -

Identifier Source: org_study_id