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

NCT ID: NCT01212926

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-28
• Study Completion Date: 2015-05-25

Brief Summary

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.

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.

Conditions

Leukemia; Cardiac Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

analysis of myocardial deformation in 2D strain

Group Type: EXPERIMENTAL

Echographic analysis of myocardial deformation in 2D strain

Intervention Type: DEVICE

Interventions

Echographic analysis of myocardial deformation in 2D strain

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane Lafitte, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2009/23

Identifier Type: -

Identifier Source: org_study_id