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Completed

NCT Number: NCT03600246

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Prevalence of OSA (%)

    Time frame: 1 day during sleep

    Incidence rate (%) of obstructive sleep apnea

Secondary outcomes

  1. MACCE (%)

    Time frame: 1 year

    Incidence rate (%) of MACCE defined as composite endpoint of all-cause death, myocardial infarction, any revacularization and stroke

  2. All-cause death (%)

    Time frame: 1 year

    Incidence rate (%) of all-cause death

  3. Any myocardial infarction (%)

    Time frame: 1 year

    Incidence rate (%) of any myocardial infarction

  4. Any revascularization (%)

    Time frame: 1 year

    Incidence rate (%) of any revascularization

  5. Stroke (%)

    Time frame: 1 year

    Incidence rate (%) of stroke

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • Dong-A ST Co., Ltd.

Registry information

Acronym: OSAAMI

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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