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

This study has been completed.
Sponsor:
Collaborator:
Inovise Medical
Information provided by:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00541801
First received: October 8, 2007
Last updated: June 22, 2011
Last verified: June 2011
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of clinically overt congestive heart failure [ Time Frame: One year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with malignant disease with scheduled anthracycline and trastuzumab therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Paul Erne, Kantonsspital Luzern
ClinicalTrials.gov Identifier: NCT00541801     History of Changes
Other Study ID Numbers: Audicor-Oncology
Study First Received: October 8, 2007
Last Updated: June 22, 2011
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014