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

27. mai 2026 oppdatert av: University Hospital, Bordeaux

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Pessac, Frankrike, 33604
        • Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: analysis of myocardial deformation in 2D strain
Enhet: Echographic analysis of myocardial deformation in 2D strain

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Bordeaux

Etterforskere

  • Hovedetterforsker: Stéphane Lafitte, MD-PhD, University Hospital Bordeaux, France

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. september 2010

Primær fullføring (Faktiske)

1. mai 2014

Studiet fullført (Faktiske)

25. mai 2015

Datoer for studieregistrering

Først innsendt

29. september 2010

Først innsendt som oppfylte QC-kriteriene

30. september 2010

Først lagt ut (Antatt)

1. oktober 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mai 2026

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHUBX 2009/23
  • 2009-A01186-51 (Annen identifikator: ANSM)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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