The Impact of Obstructive Sleep Apnea on the Outcomes in Patients of First-Time Acute Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00854997
First received: January 12, 2009
Last updated: March 1, 2009
Last verified: February 2009
  Purpose

Objective: Untreated OSA is associated with three fold risk of fetal and non-fetal cardiovascular events than control subjects in the long-term follow up. However, the prevalence rate and impact of OSA in patients with acute myocardial infarction (AMI) was not clear so far. The conflicts of studies come from variable period of AMI, heart function at enrollment, techniques used to diagnose OSA, time to revascularization, and target endpoint. Therefore, this project aimed to study the patients of first-time, Killip I-II, and post primary percutaneous coronary intervention (PCI) AMI in both and chronic phase to achieve four goals:

Aim 1. To determine the prevalence rate of OSA in patients with first-time AMI The acute phase of AMI was defined as within 14 days of the onset of AMI and the chronic phase was defined as > 14 days of onset. Eligible patients were screened with polysomnography within 5th to 7th days and 6th months of AMI to determine the prevalence rate of OSA in the AMI. Patients who had AHI more than 15/hr were considered as suffering from OSA.

Aim 2. To identify the clinical characteristics and risk factors in AMI patients associated with OSA Patients were followed up at clinics for five years. The baseline demographics of patients with or without OSA were compared to determine the factors associated with OSA in AMI patients.

Aim 3. To study the impact of OSA on the prognosis of AMI patients after revascularizaton The primary endpoint was mortality rate and cardiac events. The secondary endpoint was left ventricular function and variables related to cardiovascular disease (CVD) and metabolic syndrome. The impact of OSA on AMI was determined by comparing primary and secondary endpoint between AMI patients with and without OSA.

Aim 4. To identify the clinical and molecular factors attributing to AMI in OSA patients Factors attributing to AMI in OSA patients were determined by comparing the clinical data and mRNA expression of angiogenesis and other related genes in OSA patients with the acute phase of AMI and patients without major CVD.


Condition
Sleep Apnea, Obstructive
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Obstructive Sleep Apnea on the Outcomes in Patients of First-Time Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • mortality rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • left ventricular function and variables related to cardiovascular disease (CVD) and metabolic syndrome. [ Time Frame: 36months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, plasma, RNA, DNA


Estimated Enrollment: 120
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
AMI with OSA
2
AMI without OSA

Detailed Description:

Objectives: Obstructive sleep apnea (OSA) affects 4% middle-aged men and 2% women. Symptoms of OSA include snore, unrefresh sleep, witnessed apnea, excessive daytime sleepiness and hypertension. Untreated OSA patients are associated with three fold risk of fetal and non-fetal cardiovascular events than control subjects. However, the prevalence rate and impact of OSA in patients with acute myocardial infarction (AMI) was not clear so far. The conflicts of studies come from variable period of AMI, heart function at enrollment, techniques used to diagnose OSA, time to revascularization, and target endpoint. Therefore, this project aimed to achieve the four goals: (1) To determine the prevalence rate of OSA in patients with first-time AMI (2) To identify the clinical characteristics and risk factors in AMI patients associated with OSA (3) To study the impact of OSA on the prognosis of AMI patients after revascularization (4) To identify the clinical and molecular factors attributing to AMI in OSA patients Study design: Longitudinal, observational study Participants: AMI patients who were first-time, Killip I-II, post primary percutaneous coronary intervention (PCI) were eligible for this study. Exclusion criteria included: refuse to participate, require mechanical ventilation, active neurologic event, chronic pulmonary disease, active infection, need sedatives or narcotics within 3 days of sleep study, and participate in other study at the same time.

Protocol: Eligible patients were screened with polysomnography (PSG) within 5th to 7th days after onset of AMI. Patients who had AHI more than 15/hr were considered as suffering from OSA. Patients were followed up for five years. The primary endpoint was mortality rate and cardiac events. The secondary endpoint was left ventricular function and variables related to cardiovascular disease (CVD) and metabolic syndrome. The acute phase of AMI was defined as within 14 days of the onset of AMI and the chronic phase was defined as > 14 days of onset.

Statistic: The baseline demographics of patients with or without OSA were compared to determine the factors associated with OSA in AMI patients. The impact of OSA on AMI in acute and chronic phase was determined by comparing the mortality rate, incidences of cardiac events, left ventricular function, CVD risk factors, and metabolic profiles between AMI patients with and without OSA. Factors attributing to AMI in OSA patients were determined by comparing the clinical data and mRNA expression of angiogenesis and other related genes in OSA patients with the acute phase of AMI and patients without major CVD.

Clinical implication: Because the prevalence rate of OSA in patients of first-time AMI but no significant heart failure was extremely high, early PSG screening and identifying factors associated with OSA will allow for early diagnosis and intervention. Understanding interaction between OSA and AMI will help prevent the morbidity and mortality in AMI patients. Also, it allows for prediction of cardiovascular outcomes and early management in OSA patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

first-time, Killip I-II, post primary PCI within 5th -7th day of AMI

Criteria

Inclusion Criteria:

  • first-time, Killip I-II, post primary PCI within 5th -7th day of AMI

Exclusion Criteria:

  • refuse to participate, require mechanical ventilation, active neurologic event, chronic pulmonary disease, active infection, need sedatives or narcotics within 3 days of sleep study, and participate in other study at the same time
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854997

Contacts
Contact: Peilin Lee, M.D. +886-2-23123456 ext 3543 peilin1986@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Peilin Lee, M.D.    +886-2-23123456 ext 3543    peilin1986@yahoo.com.tw   
Principal Investigator: Peilin Lee, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Peilin Lee, M.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Peilin Lee, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00854997     History of Changes
Other Study ID Numbers: 200812080R
Study First Received: January 12, 2009
Last Updated: March 1, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Obstructive sleep apnea; myocardial infarction

Additional relevant MeSH terms:
Apnea
Infarction
Myocardial Infarction
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Cardiovascular Diseases
Dyssomnias
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014