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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Acute Myocardial Infarction
• Intervention / Treatment: Device: WATCH-PAT

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Wonju, Korea, Republic of, 26426
    • WonJu Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed with acute myocardial infarction and treated percutaneous coronary intervention

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Collaborators: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Jun-Won Lee, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2018
• Primary Completion (ACTUAL): June 10, 2020
• Study Completion (ACTUAL): July 29, 2020

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Myocardial Infarction; Infarction; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: WATCHPAT-AMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No