Clinical trial NCT03600246: Prospective Observational Registry for Obstructive Sleep Apnea in Patients With Acute Myocardial Infarction
Official title: Prospective Observational Registry for Obstructive Sleep Apnea in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Acute Myocardial Infarction
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A ST Co., Ltd.
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who diagnosed with acute myocardial infarction and treated percutaneous coronary intervention

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of OSA (%)
timeFrame: 1 day during sleep
Secondary outcomes:
measure: MACCE (%)
timeFrame: 1 year
measure: All-cause death (%)
timeFrame: 1 year
measure: Any myocardial infarction (%)
timeFrame: 1 year
measure: Any revascularization (%)
timeFrame: 1 year
measure: Stroke (%)
timeFrame: 1 year
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Assistant professor
name: Jun-Won Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: