Back to resultsAcoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography
Primary Purpose
Heart Failure, Congestive, Antineoplastic Agents
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Doppler-echocardiography and acoustic cardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure, Congestive
Eligibility Criteria
Inclusion Criteria:
- Patients with malignant disease with scheduled anthracycline and trastuzumab therapy
Sites / Locations
- Kantonsspital Luzern, Department of Cardiology
Outcomes
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
Secondary Outcome Measures
Development of clinically overt congestive heart failure
Full Information
NCT ID
NCT00541801
First Posted
October 8, 2007
Last Updated
June 22, 2011
Sponsor
Luzerner Kantonsspital
Collaborators
Inovise Medical
1. Study Identification
Unique Protocol Identification Number
NCT00541801
Brief Title
Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography
Official Title
Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography in Patients With Cytostatic Therapies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Luzerner Kantonsspital
Collaborators
Inovise Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Antineoplastic Agents
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Doppler-echocardiography and acoustic cardiography
Intervention Description
Patients receive a Doppler-echocardiography and an acoustic cardiography
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Development of clinically overt congestive heart failure
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with malignant disease with scheduled anthracycline and trastuzumab therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Erne, MD
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Luzern, Department of Cardiology
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography
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