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Clinical Trials/NCT03600246
NCT03600246
Completed
Not Applicable

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

Wonju Severance Christian Hospital1 site in 1 country100 target enrollmentJune 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Wonju Severance Christian Hospital
Enrollment
100
Locations
1
Primary Endpoint
Prevalence of OSA (%)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2018
End Date
July 29, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wonju Severance Christian Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jun-Won Lee

Assistant professor

Wonju Severance Christian Hospital

Eligibility Criteria

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
  • History of malignancy
  • Expected life span \<12 months
  • Inability to provide informed consent

Outcomes

Primary Outcomes

Prevalence of OSA (%)

Time Frame: 1 day during sleep

Incidence rate (%) of obstructive sleep apnea

Secondary Outcomes

  • MACCE (%)(1 year)
  • Any revascularization (%)(1 year)
  • All-cause death (%)(1 year)
  • Any myocardial infarction (%)(1 year)
  • Stroke (%)(1 year)

Study Sites (1)

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