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Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping

NCT03940625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2022-05-25

No results posted yet for this study

Summary

Anthracyclines (e.g. Doxorubicin) are an important and highly effective chemotherapeutic. They are used in various tumor entities and are established for breast cancer treatment. The most significant prognostic side effect is cardiotoxicity, which occurs in up to 50 patients. Female gender must be considered an independent risk factor for the incidence and severity of associated heart failure. The aim of this study is to demonstrate that dose-dependent anthracycline-induced cardiotoxicity has a measurable effect on T2 mapping on MRI. The second aim is to demonstrate if the combination of diastolic strain (echo and MRI) and T2 mapping can detect earlier anthracycline-induced myocardial damage than via the established method of the echocardiographic measurement of LV-EF and the conventional quantification of diastolic function.

Conditions

Interventions

DIAGNOSTIC_TEST

Cardiac MRI and echocardiography, laboratory parameters

Cardiac MRI including cine imaging (volumetric determination of LV-EF), late gadolinium enhancement, strain analysis, T1 mapping and T2 mapping Echocardiography including 3D-EF, diastolic function and strain analysis Determination of laboratory parameters including cardiac enzymes (Troponin T and high sensitivity Troponin T) and cardiac markers (BNP and NT-pro BNP)

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-03
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940625 on ClinicalTrials.gov