Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00541801
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Inovise Medical
Information provided by:
Luzerner Kantonsspital

Tracking Information
First Submitted Date  ICMJE October 8, 2007
First Posted Date  ICMJE October 10, 2007
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE March 2007
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Development of clinically overt congestive heart failure [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography
Official Title  ICMJE Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography in Patients With Cytostatic Therapies
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Heart Failure, Congestive
  • Antineoplastic Agents
Intervention  ICMJE Device: Doppler-echocardiography and acoustic cardiography
Patients receive a Doppler-echocardiography and an acoustic cardiography
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with malignant disease with scheduled anthracycline and trastuzumab therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541801
Other Study ID Numbers  ICMJE Audicor-Oncology
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Erne, Kantonsspital Luzern
Study Sponsor  ICMJE Luzerner Kantonsspital
Collaborators  ICMJE Inovise Medical
Investigators  ICMJE
Study Chair: Paul Erne, MD Luzerner Kantonsspital
PRS Account Luzerner Kantonsspital
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP