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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00541801
First Posted: October 10, 2007
Last Update Posted: June 27, 2011
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.
Collaborator:
Inovise Medical
Information provided by:
Luzerner Kantonsspital
  Purpose
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 Intervention
Heart Failure, Congestive Antineoplastic Agents Device: Doppler-echocardiography and acoustic cardiography

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • 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:
  • Development of clinically overt congestive heart failure [ Time Frame: One year ]

Study Start Date: March 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Doppler-echocardiography and acoustic cardiography
    Patients receive a Doppler-echocardiography and an acoustic cardiography
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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with malignant disease with scheduled anthracycline and trastuzumab therapy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00541801


Locations
Switzerland
Kantonsspital Luzern, Department of Cardiology
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Inovise Medical
Investigators
Study Chair: Paul Erne, MD Luzerner Kantonsspital
  More Information

Responsible Party: Paul Erne, Kantonsspital Luzern
ClinicalTrials.gov Identifier: NCT00541801     History of Changes
Other Study ID Numbers: Audicor-Oncology
First Submitted: October 8, 2007
First Posted: October 10, 2007
Last Update Posted: June 27, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases