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NCT00541801 Clinical Trial

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

Heart Failure, Congestive Clinical Trial

Official title:
Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography in Patients With Cytostatic Therapies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00541801
Other study ID # Audicor-Oncology
Secondary ID
Status Completed
Phase N/A
First received October 8, 2007
Last updated June 22, 2011
Start date March 2007
Est. completion date June 2011

Study information
Verified date June 2011
Source Luzerner Kantonsspital
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with malignant disease with scheduled anthracycline and trastuzumab therapy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland Kantonsspital Luzern, Department of Cardiology Luzern

Sponsors (2)
Lead Sponsor Collaborator
Luzerner Kantonsspital Inovise Medical

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes of echocardiographic parameters and changes of electromechanical activation time (EMAT)and development of third heart sound as indicators of congestive heart failure Repeated measurements over a year No
Secondary Development of clinically overt congestive heart failure One year No
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