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Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00541801
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : June 27, 2011
Inovise Medical
Information provided by:
Luzerner Kantonsspital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Antineoplastic Agents Device: Doppler-echocardiography and acoustic cardiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography in Patients With Cytostatic Therapies
Study Start Date : March 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Intervention Details:
  • Device: Doppler-echocardiography and acoustic cardiography
    Patients receive a Doppler-echocardiography and an acoustic cardiography

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Development of clinically overt congestive heart failure [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with malignant disease with scheduled anthracycline and trastuzumab therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00541801

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Kantonsspital Luzern, Department of Cardiology
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Inovise Medical
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Study Chair: Paul Erne, MD Luzerner Kantonsspital
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Responsible Party: Paul Erne, Kantonsspital Luzern Identifier: NCT00541801    
Other Study ID Numbers: Audicor-Oncology
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases