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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Pessac, France, 33604
- Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: analysis of myocardial deformation in 2D strain
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.
Délai: 6 weeks
|
6 weeks
|
|
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.
Délai: 3 months
|
3 months
|
|
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.
Délai: 6 months
|
6 months
|
|
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.
Délai: 9 months
|
9 months
|
|
determination of longitudinal myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.
Délai: 12 months
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.
Délai: 6 weeks
|
6 weeks
|
|
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.
Délai: 3 months
|
3 months
|
|
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.
Délai: 6 months
|
6 months
|
|
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.
Délai: 9 months
|
9 months
|
|
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.
Délai: 12 months
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Stéphane Lafitte, MD-PhD, University Hospital Bordeaux, France
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Blessures et Blessures
- Processus pathologiques
- Tumeurs
- Maladies cardiaques
- Tumeurs par type histologique
- Maladies hématologiques
- Troubles induits chimiquement
- Effets secondaires et effets indésirables liés aux médicaments
- Blessures par rayonnement
- Conditions pathologiques, signes et symptômes
- Maladies hémiques et lymphatiques
- Leucémie
- Cardiotoxicité
Autres numéros d'identification d'étude
- CHUBX 2009/23
- 2009-A01186-51 (Autre identifiant: ANSM)
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