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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pessac, França, 33604
- Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: analysis of myocardial deformation in 2D strain
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.
Prazo: 6 weeks
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6 weeks
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determination of longitudinal myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.
Prazo: 3 months
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3 months
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determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.
Prazo: 6 months
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6 months
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determination of longitudinal myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.
Prazo: 9 months
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9 months
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determination of longitudinal myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.
Prazo: 12 months
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12 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.
Prazo: 6 weeks
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6 weeks
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determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.
Prazo: 3 months
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3 months
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determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.
Prazo: 6 months
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6 months
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determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.
Prazo: 9 months
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9 months
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determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.
Prazo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stéphane Lafitte, MD-PhD, University Hospital Bordeaux, France
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimado)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças cardiovasculares
- Ferimentos e Lesões
- Processos Patológicos
- Neoplasias
- Doenças cardíacas
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Distúrbios induzidos quimicamente
- Efeitos colaterais e reações adversas relacionados a medicamentos
- Lesões por Radiação
- Condições Patológicas, Sinais e Sintomas
- Doenças hemic e linfáticas
- Leucemia
- Cardiotoxicidade
Outros números de identificação do estudo
- CHUBX 2009/23
- 2009-A01186-51 (Outro identificador: ANSM)
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