Obstructive Sleep Apnea and Acute Myocardial Infarction and the Role of Continuous Positive Airway Pressure (CPAP)Treatment

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00821210
First received: January 12, 2009
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

Specific Aim

  1. To determine the prevalence of OSA in patients of first-time AMI in acute phase By screening patients of first-time, single-vessel disease, Killip I AMI, and successful revascularization
  2. To determine the impact of CPAP treatment on the prognosis of AMI Using sham CPAP as the optimal placebo, we conduct this randomized, double-blind, placebo controlled trial to assess the 12-week CPAP effect in moderate-severe OSA patients.
  3. To determine how the OSA affects patients with MI in acute and chronic phase and vice versa, which is dissected from mechanical basis and molecular basis By comparing the clinical parameters of AMI patients without OSA (AHI<5/hr), mild OSA (5 < AHI <15), moderate OSA (15<AHI<30) and severe OSA5 (AHI>30/hr), and before and after CPAP treatment, we can determine the interaction between OSA and AMI.

Condition Intervention
Sleep Apnea, Obstructive
Acute Myocardial Infarction
Device: Sham CPAP
Device: CPAP of optimal pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apnea and Acute Myocardial Infarction and the Role of CPAP Treatment: a Double -Blind, Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Primary goal: Intervention: Improvement of LVEF by 7%, decrease the left ventricular end-systolic dimension by 3 mm, 3D echo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of stroke and fetal, non-fetal cardiac event [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2008
Study Completion Date: November 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 2 Device: Sham CPAP
CPAP with pressure of 3cm H2O
Active Comparator: 1 Device: CPAP of optimal pressure
CPAP of optimal pressure

Detailed Description:

Obstructive sleep apnea (OSA) is a major public health problem affecting at least 2-4% of middle-aged population. OSA resulted in hypoxia and sleep fragmentation, which resulted in neurocognitive dysfunction and cardiovascular sequelaes. The cardiovascular sequelaes in OSA included hypertension, coronary artery disease and heart failure. Our data showed among 599 moderate-sever OSA (AHI<15/hr), 44.5% patients had cardiovascular disease, which included 41.4% having hypertension,7% having CAD and 2.4% having congestive heart failure。 Though OSA is well known to be highly correlated with fatal and non-fatal cardiac event, only limited studies investigated how OSA affected acute myocardial infarction (AMI). Most studies concluded that AMI would worsen OSA and vice versa. However, how AMI exactly interacts with OSA and what the prevalence of OSA in the first-time AMI is have never been answered. Within four weeks from Nov. 15th 2007, we screened ten patients of first-time AMI with single-vessel disease and Killip I. Five in 10 received PSG and three in five have moderate OSA.

So far, CPAP is the standard treatment for patients with moderate to severe OSA. CPAP could improve airway patency, daytime sleepiness, functional status, blood pressure, metabolic abnormalities and quality of life. In our study, we enrolled 24 non-sleepy OSA and 30 sleepy OSA to study the four-week CPAP effect. The results showed the apnea-hypopnea index, hypoxia, arousal, sleepiness and fatigue could be corrected with CPAP treatment in both groups. However, CPAP could only lower risk factors for cardiovascular disease, like blood pressure, epinephrine, norepinephrine and CRP, in sleepy OSA. Our finding supported that CPAP effect was not similar in the subgroups of severe OSA, so CPAP effect should be studied in every subgroup of OSA patients before it's applied. Till now, there's no literatures reported if CPAP treatment would decrease the morbidity and mortality of AMI.

Sham CPAP mimicked all the characteristics of a true CPAP except for the null pressure, which was recently used as the placebo to study CPAP effect. Therefore, using this optimized placebo, we propose this double-blind, control randomized trial (1) To determine the prevalence of OSA in patients of first-time AMI in acute phase; (2) To determine the impact of CPAP treatment on the prognosis of AMI; (3) Determine how the OSA affects patients with MI in acute and chronic phase and vice versa, which is dissected from mechanical basis and molecular basis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. First-time AMI
  2. s/p revascularization (successful primary PTCA for ischemia-related artery)
  3. Killip I

Exclusion Criteria:

  1. Refuse to participate
  2. Require mechanical ventilation
  3. Having active neurologic event, severe obstructive airway disease and active infection, active malignancy
  4. Need sedative drug or narcotics during the study period within 3 days of PSG
  5. Participates other study at the same time
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00821210

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chong-Jen Yu, M.D. National Taiwan University Hospital
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: NCT00821210     History of Changes
Other Study ID Numbers: 200712052R
Study First Received: January 12, 2009
Last Updated: November 30, 2010
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014