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Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction


N/A
18 Years
75 Years
Open (Enrolling)
Female
Left Ventricular Function Systolic Dysfunction, Cardiotoxicity

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Trial Information

Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction


The investigators will prospectively evaluate whether changes in tissue deformation,
assessed by myocardial strain and strain rate (SR) and identify possibility of early
detection of LV dysfunction in patients treated with trastuzumab.


Inclusion Criteria:



- HER2(+) breast cancer, anticipating Trastuzumab therapy

Exclusion Criteria:

- Refusal to informed consent

- Congenital heart disease

- Significant arrhythmia in EKG

- Regional wall motion abnormality (+) in echocardiography

- Poor sonic window

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

LV systolic dysfunction

Outcome Description:

LV systolic dysfunction was defined as following; An EF unit drop of ≥10% from the baseline available echocardiogram or Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram

Outcome Time Frame:

3-month F/U

Safety Issue:

No

Principal Investigator

Hyung-Kwan Kim, M.D., PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

H1106-026-365

NCT ID:

NCT01665300

Start Date:

July 2011

Completion Date:

December 2013

Related Keywords:

  • Left Ventricular Function Systolic Dysfunction
  • Cardiotoxicity
  • myocardial deformation imaging
  • Trastuzumab

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