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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Pessac, Frankrig, 33604
- Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: analysis of myocardial deformation in 2D strain
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 12 months
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12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 6 months
|
6 months
|
|
determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.
Tidsramme: 9 months
|
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.
Tidsramme: 12 months
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12 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Stéphane Lafitte, MD-PhD, University Hospital Bordeaux, France
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Sår og skader
- Patologiske processer
- Neoplasmer
- Hjertesygdomme
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Kemisk inducerede lidelser
- Lægemiddelrelaterede bivirkninger og uønskede reaktioner
- Strålingsskader
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Leukæmi
- Kardiotoksicitet
Andre undersøgelses-id-numre
- CHUBX 2009/23
- 2009-A01186-51 (Anden identifikator: ANSM)
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