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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00821210 |
Specific Aim
Condition | Intervention |
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Sleep Apnea, Obstructive Acute Myocardial Infarction |
Device: Sham CPAP Device: CPAP of optimal pressure |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Obstructive Sleep Apnea and Acute Myocardial Infarction and the Role of CPAP Treatment: a Double -Blind, Randomized Control Trial |
Estimated Enrollment: | 120 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Sham Comparator |
Device: Sham CPAP
CPAP with pressure of 3cm H2O
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1: Active Comparator |
Device: CPAP of optimal pressure
CPAP of optimal pressure
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peilin Lee, M.D. | +886-2-23123456 ext 3543 | peilin1986@yahoo.com.tw |
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. |
Principal Investigator: | Chong-Jen Yu, M.D. | National Taiwan University Hospital |
Principal Investigator: | Peilin Lee, M.D. | National Taiwan University Hospital |
Responsible Party: | National Taiwan University Hospital ( Peilin Lee ) |
Study ID Numbers: | 200712052R |
Study First Received: | January 12, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00821210 |
Health Authority: | Taiwan: Department of Health |
Obstructive sleep apnea myocardial infarction |
Sleep Apnea Syndromes Heart Diseases Apnea Myocardial Ischemia Sleep Apnea, Obstructive Respiration Disorders Vascular Diseases Dyssomnias Sleep Disorders |
Ischemia Sleep Disorders, Intrinsic Signs and Symptoms Necrosis Respiratory Tract Diseases Signs and Symptoms, Respiratory Infarction Myocardial Infarction |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |