Preemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients

This study is not yet open for participant recruitment.
Verified June 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01616121
First received: May 31, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedance-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.


Condition Intervention Phase
Heart Failure
Other: Usual treatment of patients with developing acute heart failure
Device: Lung Impedance-Guided Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Prevention of acute heart failure development in acute MI patients [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of clinical outcome in patients with lung impedance-guided treatments [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Treatment Heart Failure Other: Usual treatment of patients with developing acute heart failure
Active Comparator: Lung Impedance-Guided Therapy Device: Lung Impedance-Guided Therapy
Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure

Exclusion Criteria:

  • Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616121

Contacts
Contact: Michael Shochat, MD, PhD 972-50-6246926 shochat1@yahoo.com

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Michael Shochat, MD, PhD         
Principal Investigator: Michael Shochat, MD, PhD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01616121     History of Changes
Other Study ID Numbers: 0037-12-HYMC
Study First Received: May 31, 2012
Last Updated: June 7, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on April 20, 2014