Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

This study is currently recruiting participants.

Verified April 2013 by Seoul National University Hospital

Sponsor:

Information provided by (Responsible Party):

Hyung-Kwan Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01665300

First received: December 13, 2011

Last updated: April 11, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2011

Last Updated Date

April 11, 2013

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

LV systolic dysfunction [ Time Frame: 3-month F/U ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

LV systolic dysfunction [ Time Frame: 3,6,9, and 12-month F/U ] [ Designated as safety issue: No ]

an EF unit drop of ≥10% from the first available echocardiogram
decrease in strain or strain rate : drop corresponding to ≥1 SD of the relevant parameter assessed at the first available echocardiogram

Change History

Complete list of historical versions of study NCT01665300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

LV systolic dysfunction [ Time Frame: 6,9, and 12-month F/U ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

Official Title ^ICMJE

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

Brief Summary

Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type 2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment has been mandated to detect myocardial dysfunction because of the risk of heart failure with this treatment. Myocardial deformation imaging is a sensitive means of detecting LV dysfunction, but this technique has not been evaluated in patients treated with trastuzumab. The aim of this study was to investigate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than conventional echocardiographic measures in patients treated with trastuzumab.

Detailed Description

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

genetic susceptibility for HER2(+)cardiotoxicity

Sampling Method

Non-Probability Sample

Study Population

The investigators evaluated serial echocardiograms (baseline, 3, 6, 9, and 12 months)from 120 consecutive female patients receiving trastuzumab as part of their treatment for either early or advanced breast cancer.

Condition ^ICMJE

Left Ventricular Function Systolic Dysfunction
Cardiotoxicity

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ji-Hyun Kim, M.D.	82-2-2072-3757	mdangela79@gmail.com
Contact: Hyung-Kwan KIm, M.D., Ph.D.	82-2-2072-0243	cardiman73@gmail.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01665300

Other Study ID Numbers ^ICMJE

H1106-026-365

Has Data Monitoring Committee

Responsible Party

Hyung-Kwan Kim, Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hyung-Kwan Kim, M.D., PhD

Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

April 2013

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

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