Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity
1 other identifier
interventional
100
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2018
CompletedFirst Submitted
Initial submission to the registry
March 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 24, 2024
March 1, 2024
6.9 years
March 18, 2024
June 20, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2)
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) gene as biomarker of fibrosis
1 month
Evaluation of blood levels of Galectin-3 (Gal-3)
Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis
1 month
Evaluation of Enhanced Liver Fibrosis score (ELF)
Evaluation of Enhanced Liver Fibrosis score (ELF) as biomarker of fibrosis ELF score is a "marker set" constituted by 3 markers of fibrosis: lhyaluronic acid, amino-terminal propeptide of type III procollagen, and tissue inhibitor of metalloproteinase 1, firstly utilized in the diagnosis and assessment of the severity of liver
1 month
Evaluation of CMR imaging marker of fibrosis
Evaluation at CMR of Myocardial T1 before and after contrast media infusion and Myocardial extracellular volume
1 month
Secondary Outcomes (3)
Evaluation of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline
1 month
Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP)
1 month
Evaluation of levels of cytochrome C
1 months
Study Arms (1)
Evaluation of myocardial fibrosis
OTHEREchocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent
Interventions
echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent
Eligibility Criteria
You may qualify if:
- Patients who developed AIC during or after anthracycline-containing therapy assessed by LVEF valuation by echocardiography.
You may not qualify if:
- Age \<18 years
- Contraindications to contrast medium magnetic resonance imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European Institute of Oncology
Milan, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Cardinale, MD
European Institute of Oncology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2024
First Posted
March 26, 2024
Study Start
February 22, 2018
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 24, 2024
Record last verified: 2024-03