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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014