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Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain

18 Years
65 Years
Open (Enrolling)
Leukemia, Cardiac Toxicity

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Trial Information

Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain

Analysis of myocardial deformation in its longitudinal component, circumferential and
radial, is a new echocardiographic technique for evaluating myocardial function, which has
demonstrated its superiority compared to LVEF in many clinical situations. It therefore
seems promising to evaluate this new tool in the earlier detection of adverse myocardial
chemotherapy with anthracyclines. The ultimate goal is indeed to determine a reliable and
reproducible parameter for cardiac toxicity diagnostic to avoid chemotherapy interruption,
thus improving the survival of these patients.

The main objective of this project is to evaluate the association between changes in
myocardial deformation longitudinal 2D strain echocardiography between baseline and 6 weeks
after initiation of anthracycline therapy for acute leukemia and the occurrence of impaired
left ventricular function within 12 months after starting treatment.

It is a prognostic study of clinical-looking, without randomization. The inclusion will take
place over a period of 12 months with a total follow-up of 12 months.

The analysis will focus on the identification of parameters predictive of alteration of Fe

Inclusion Criteria:

- Patient female or male aged between 18 and 65

- Patients with a haematological disease and ran for a first-line chemotherapy
including anthracycline

- Patients with a predict cardiovascular score to 10 years below 20% or if higher, with
a stress echocardiography using dobutamine, negative, for less than six months.

- Patient or affiliate receiving social security

- Patient informed consent and having oral and written

Exclusion Criteria:

- A history of chemotherapy or radiotherapy of the left hemithorax

- Significant coronary artery disease: a history of angioplasty, stent, CABG, predict
cardiovascular score to 10 years over 20% of stress echocardiography and dobutamine
positive (three positive segments)

- Left ventricular hypertrophy (diastolic septum ≥ 10 mm and diastolic posterior wall
≥ 10 mm)

- One or more significant valvulopathy: Rao, RM medium or tight, IM, IT and CAI ≥ grade

- Secondary or primary cardiomyopathy (LVEF ≤ 50%)

- Pregnant or lactating

Type of Study:


Study Design:

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

Outcome Measure:

determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Stéphane Lafitte, MD-PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Bordeaux, France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2009/23



Start Date:

September 2010

Completion Date:

September 2014

Related Keywords:

  • Leukemia
  • Cardiac Toxicity
  • Leukemia