Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity

NCT ID: NCT06331806

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2024-12-31

Brief Summary

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This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment

Detailed Description

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The main aim of this interventional study is to evaluate biochemical and imaging markers of fibrosis in patients who had previously developed AIC during or after anthracycline-containing therapy.

Anthracycline-induced cardiomyopathy (AIC) is define as a reduction in Left Ventricular Ejection Fraction (LVEF) \>10% units from baseline and below 50%, assessed by echocardiography, during or after anthracycline-containing therapy.

All patients will undergo:

* at time 0

* an echocardiogram with LVEF evaluation (biplane method)
* a single blood sample.
* at time 1 - a Cardiac Magnetic Resonance (RMC) with contrast agent (T1 mapping technique) (time 1 = within 72 hours from blood sample).

Conditions

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Cardiomyopathy Due to Drug

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Evaluation of myocardial fibrosis

Echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent

Group Type OTHER

Evaluation of myocardial fibrosis

Intervention Type DIAGNOSTIC_TEST

echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent

Interventions

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Evaluation of myocardial fibrosis

echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients who developed AIC during or after anthracycline-containing therapy assessed by LVEF valuation by echocardiography.

Exclusion Criteria

* Age \<18 years
* Contraindications to contrast medium magnetic resonance imaging
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniela Cardinale, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

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European Institute of Oncology

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Daniela Cardinale, MD

Role: CONTACT

+39 0257489748

Facility Contacts

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Daniela Cardinale, MD

Role: primary

Other Identifiers

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IEO 398

Identifier Type: -

Identifier Source: org_study_id

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