Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography
June 22, 2011 updated by: Luzerner Kantonsspital
Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography in Patients With Cytostatic Therapies
In this study, the investigators sought to determine whether an acoustic cardiographic assessment of heart function is equivalent to Doppler-echocardiography in patients who are treated with cardio-toxic cytostatic agents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients receiving cardio-toxic cytostatic agents are examined by Doppler-echocardiography and acoustic cardiography before, during, and after the cytostatic treatment.
Doppler-echocardiography measures ejection fraction, TDI, speckle tracking, and further parameters.
Acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA) simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures.
Heart function as assessed by Doppler-echocardiography is then compared to the heart function as assessed by Audicor ECG.
Study Type
Interventional
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
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Luzern, Switzerland, 6000
- Kantonsspital Luzern, Department of Cardiology
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with malignant disease with scheduled anthracycline and trastuzumab therapy
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes of echocardiographic parameters and changes of electromechanical activation time (EMAT)and development of third heart sound as indicators of congestive heart failure
Time Frame: Repeated measurements over a year
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Repeated measurements over a year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Development of clinically overt congestive heart failure
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Paul Erne, MD, Luzerner Kantonsspital
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
March 1, 2007
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
October 8, 2007
First Submitted That Met QC Criteria
October 9, 2007
First Posted (Estimate)
October 10, 2007
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 22, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Audicor-Oncology
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.