- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01264159
Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
June 10, 2020 updated by: Hillel Yaffe Medical Center
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 impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization
Exclusion Criteria:
- Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
|
Active Comparator: Lung impedence-guided treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevention of acute heart failure development in acute MI patients
Time Frame: Three years
|
Three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of clinical outcome in patients with lung impedence-guided treatments
Time Frame: Three years
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
December 20, 2010
First Submitted That Met QC Criteria
December 20, 2010
First Posted (Estimate)
December 21, 2010
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 10, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0090-10-HYMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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