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Noninvasive Ventilation in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristina Marcia Dias, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier:
NCT01484795
First received: November 30, 2011
Last updated: December 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
 Device: BILEVEL (Respironics)
Device: Continuos positive airway pressure (Respironics)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Non Invasive Ventilation in Acute Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Centro Universitário Augusto Motta:

Primary Outcome Measures:
  • evaluate HRV during NIV after acute myocardial infarction [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 10
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous positive airway pressure Device: Continuos positive airway pressure (Respironics)
CPAP was delivered by a ventilator (Respironics Inc, Murrysville, PA), applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O.
Other Name: CPAP
Experimental: BILEVEL Device: BILEVEL (Respironics)
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.
Other Name: BIPAP

Detailed Description:

The patients will be recruited in Bonsucesso Federal Hospital with diagnosis of myocardial infarction, confirmed by electrocardiogram and cardiac enzymes, between 24 and 72 hours after the event.

Participation in the study protocol will be done according to eligibility criteria:

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

CPAP will be applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O. Bilevel will be applied via facial mask, with inspiratory positive pressure (IPAP) of 20 cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 45 to 80 years old age.

Exclusion Criteria:

  • unstable angina;
  • systolic blood pressure < 80 mmHg;
  • patients who presented ST elevation > 2 mm or with second-degree atrioventricular block;
  • presence of pacemaker.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484795

Sponsors and Collaborators
Centro Universitário Augusto Motta
Investigators
Principal Investigator: Cristina M Dias, PT - PhD Centro Universitário Augusto Motta
  More Information

No publications provided

Responsible Party: Cristina Marcia Dias, PhD, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT01484795     History of Changes
Other Study ID Numbers: Cristina Dias
Study First Received: November 30, 2011
Last Updated: December 1, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Centro Universitário Augusto Motta:
noninvasive ventilation
autonomic nervous system

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013