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

NCT00854997 | Unknown DMC

• 1 other identifier: 200812080R
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive; Acute Myocardial Infarction

Keywords

Obstructive sleep apnea; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• mortality rate

  36 months

Secondary Outcomes (1)

• left ventricular function and variables related to cardiovascular disease (CVD) and metabolic syndrome.

  36months

Study Arms (2)

1

AMI with OSA

2

AMI without OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, RNA, DNA

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

• Peilin Lee, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peilin Lee, M.D.

CONTACT

+886-2-23123456; peilin1986@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: March 3, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 3, 2009

Record last verified: 2009-02

Locations

TW (1)