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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01212926
First received: September 29, 2010
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Leukemia
Cardiac Toxicity
Device: Echographic analysis of myocardial deformation in 2D strain

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • determination of longitudinal myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • determination of longitudinal myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • determination of longitudinal myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: April 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: analysis of myocardial deformation in 2D strain 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01212926

Locations
France
Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Stéphane Lafitte, MD-PhD University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01212926     History of Changes
Other Study ID Numbers: CHUBX 2009/23
Study First Received: September 29, 2010
Last Updated: May 9, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 16, 2014