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

NCT03600246 | Completed

• 1 other identifier: WATCHPAT-AMI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of OSA (%)

  Incidence rate (%) of obstructive sleep apnea

  1 day during sleep

Secondary Outcomes (5)

• MACCE (%)

  1 year

• All-cause death (%)

  1 year

• Any myocardial infarction (%)

  1 year

• Any revascularization (%)

  1 year

• Stroke (%)

  1 year

Interventions

WATCH-PAT DEVICE

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 20 years
• Successful PCI in at least one major epicedial coronary artery

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• Dong-A ST Co., Ltd.: collaborator

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jun-Won Lee, MD

  Assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: June 11, 2018
• Primary Completion: June 10, 2020
• Study Completion: July 29, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)