Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain (CA2D)

It is now accepted that the anticancer properties of anthracyclines were allowed in many malignancies improve the prognosis of affected populations.

However, the cardiotoxicity of anthracyclines is responsible for an interruption of this treatment by alteration of potentially irreversible myocardial contraction and high mortality.

An earlier detection of adverse myocardial anthracycline chemotherapy would allow the adaptation of the regimen by reducing the number of interruptions of antitumor and strengthening monitoring. Optimizing the therapeutic antitumor and generate an increase in survival of patients treated.

Study Overview

• Status: Completed
• Conditions: Leukemia; Cardiac Toxicity
• Intervention / Treatment: Device: Echographic analysis of myocardial deformation in 2D strain

Detailed Description

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 VG.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 2
• Secondary or primary cardiomyopathy (LVEF ≤ 50%)
• Pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: analysis of myocardial deformation in 2D strain	Device: Echographic analysis of myocardial deformation in 2D strain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.	6 weeks
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.	3 months
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.	6 months
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.	9 months
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.	6 weeks
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.	3 months
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.	6 months
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.	9 months
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Stéphane Lafitte, MD-PhD, University Hospital Bordeaux, France

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 25, 2015

Study Registration Dates

• First Submitted: September 29, 2010
• First Submitted That Met QC Criteria: September 30, 2010
• First Posted (Estimated): October 1, 2010

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms; Heart Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia; Cardiotoxicity
• Other Study ID Numbers: CHUBX 2009/23; 2009-A01186-51 (Other Identifier: ANSM)