Noninvasive Ventilation in Acute Myocardial Infarction

NCT01484795 | Completed Phase 1 DMC

• 1 other identifier: Cristina Dias
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiovascular diseases, especially acute myocardial infarction (AMI), represent the major cause of mortality and morbidity in the world. The myocardial ischemia is often the precipitating cause of pulmonary edema and noninvasive ventilation (NIV) with positive pressure has been used as a therapeutic modality. Objective: to evaluate the effects of NIV on heart rate variability (HRV) and on ventilatory and hemodynamic variables in patients with myocardial infarction. Materials and methods: ten patients with acute myocardial infarction, with Killip I classification, will use continuous positive airway pressure (CPAP) and Bilevel ventilation during 30 minutes, according randomization. Then ventilatory and hemodynamic variables will be registered and electrocardiogram signals will be recorded for posterior analyses of HRV. Data will be collected before, during and after positive pressure ventilation. Statistical Analysis: Data will be compared using One Way Anova Repeated Measures, followed by Tukey test.

Conditions

Acute Myocardial Infarction

Keywords

noninvasive ventilation; autonomic nervous system

Outcome Measures

Primary Outcomes (1)

• evaluate HRV during NIV after acute myocardial infarction

  The study consisted of randomized and crossover clinical trial for evaluation and comparison of heart rate variability and ventilatory and hemodynamics variables during ventilation with CPAP and Bilevel.

  six months

Study Arms (2)

Continuous positive airway pressure

EXPERIMENTAL

Device: Continuos positive airway pressure (Respironics)

BILEVEL

EXPERIMENTAL

Device: BILEVEL (Respironics)

Interventions

BILEVEL (Respironics) DEVICE

Bilevel was delivered by a Bipap® ventilator (Respironics Inc, Murrysville, PA), applied via facial mask, with inspiratory positive pressure (IPAP) of 20 cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.

Also known as: BIPAP

BILEVEL

Continuos positive airway pressure (Respironics) DEVICE

CPAP was delivered by a ventilator (Respironics Inc, Murrysville, PA), applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O.

Also known as: CPAP

Continuous positive airway pressure

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute myocardial infarction with Killip I classification, hemodynamic stability, between 24 and 72 hours post event;
• agreement to participate in the study, according written informed consent;
• to 80 years old age.

You may not qualify if:

• unstable angina;
• systolic blood pressure \< 80 mmHg;
• patients who presented ST elevation \> 2 mm or with second-degree atrioventricular block;
• presence of pacemaker.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead

Study Officials

• Cristina M Dias, PT - PhD

  Centro Universitário Augusto Motta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 2, 2011

Record last verified: 2011-11