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临床试验/NCT03600246
NCT03600246已完成不适用

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

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Prevalence of OSA (%)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Prevalence of OSA (%)

时间窗: 1 day during sleep

Incidence rate (%) of obstructive sleep apnea

次要结局

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

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun-Won Lee

Assistant professor

Wonju Severance Christian Hospital

研究点 (1)

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