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

November 30, 2010 updated by: National Taiwan University Hospital

Obstructive Sleep Apnea and Acute Myocardial Infarction and the Role of CPAP Treatment: a Double -Blind, Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Device: CPAP of optimal pressure
CPAP of optimal pressure
Sham Comparator: 2
Device: Sham CPAP
CPAP with pressure of 3cm H2O

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary goal: Intervention: Improvement of LVEF by 7%, decrease the left ventricular end-systolic dimension by 3 mm, 3D echo.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of stroke and fetal, non-fetal cardiac event
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Peilin Lee, M.D., National Taiwan University Hospital
  • Principal Investigator: Chong-Jen Yu, M.D., National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

December 1, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200712052R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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