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

Primary Purpose

Leukemia, Cardiac Toxicity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echographic analysis of myocardial deformation in 2D strain
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Leukemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

analysis of myocardial deformation in 2D strain

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2010
Last Updated
February 8, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01212926
Brief Title
Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain
Acronym
CA2D
Official Title
Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2010 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 25, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Cardiac Toxicity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
analysis of myocardial deformation in 2D strain
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Echographic analysis of myocardial deformation in 2D strain
Primary Outcome Measure Information:
Title
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.
Time Frame
6 weeks
Title
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.
Time Frame
3 months
Title
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.
Time Frame
6 months
Title
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.
Time Frame
9 months
Title
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.
Time Frame
6 weeks
Title
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.
Time Frame
3 months
Title
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.
Time Frame
6 months
Title
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.
Time Frame
9 months
Title
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Lafitte, MD-PhD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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