Preemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
1 other identifier
interventional
654
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
Started Jun 2002
Longer than P75 for phase_3 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 31, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJune 19, 2020
June 1, 2020
12.1 years
May 31, 2012
June 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Prevention of acute heart failure development in acute MI patients
Three years
Secondary Outcomes (1)
Improvement of clinical outcome in patients with lung impedance-guided treatments
Three years
Study Arms (2)
Conventional Treatment Heart Failure
ACTIVE COMPARATORConventional Treatment
Lung Impedance-Guided Therapy
EXPERIMENTALLung Impedance-Guided Therapy
Interventions
Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)
Eligibility Criteria
You may qualify if:
- Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure
You may not qualify if:
- Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2012
First Posted
June 11, 2012
Study Start
June 1, 2002
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 19, 2020
Record last verified: 2020-06