Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03600246
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Jun-Won Lee, Wonju Severance Christian Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Acute Myocardial Infarction Device: WATCH-PAT

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Registry for Obstructive Sleep Apnea in Patients With Acute Myocardial Infarction
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : June 10, 2020
Actual Study Completion Date : July 29, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: WATCH-PAT
    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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prevalence of OSA (%) [ Time Frame: 1 day during sleep ]
    Incidence rate (%) of obstructive sleep apnea


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who diagnosed with acute myocardial infarction and treated percutaneous coronary intervention
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600246


Locations
Layout table for location information
Korea, Republic of
Wonju Severance Christian Hospital
Wonju, Korea, Republic of, 26426
Sponsors and Collaborators
Wonju Severance Christian Hospital
Dong-A ST Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Jun-Won Lee, MD Assistant professor
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jun-Won Lee, Assistant professor, Wonju Severance Christian Hospital
ClinicalTrials.gov Identifier: NCT03600246    
Other Study ID Numbers: WATCHPAT-AMI
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Myocardial Infarction
Infarction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Ischemia
Pathologic Processes
 Necrosis
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases