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

NCT00821210 | Completed DMC

• 1 other identifier: 200712052R
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim

1. 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. 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. 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.

Conditions

Sleep Apnea, Obstructive; Acute Myocardial Infarction

Keywords

Obstructive sleep apnea; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Primary goal: Intervention: Improvement of LVEF by 7%, decrease the left ventricular end-systolic dimension by 3 mm, 3D echo.

  12 weeks

Secondary Outcomes (1)

• incidence of stroke and fetal, non-fetal cardiac event

  12 months

Study Arms (2)

2

SHAM COMPARATOR

Device: Sham CPAP

1

ACTIVE COMPARATOR

Device: CPAP of optimal pressure

Interventions

Sham CPAP DEVICE

CPAP with pressure of 3cm H2O

2

CPAP of optimal pressure DEVICE

CPAP of optimal pressure

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time AMI
• s/p revascularization (successful primary PTCA for ischemia-related artery)
• Killip I

You may not qualify if:

• Refuse to participate
• Require mechanical ventilation
• Having active neurologic event, severe obstructive airway disease and active infection, active malignancy
• Need sedative drug or narcotics during the study period within 3 days of PSG
• Participates other study at the same time

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Myocardial Infarction

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Chong-Jen Yu, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Peilin Lee, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: January 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

TW (1)