Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity: Clinical and Prognostic Implications
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of blood levels of Galectin-3 (Gal-3)
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who developed AIC during or after anthracycline-containing therapy assessed by LVEF valuation by echocardiography.
排除标准
- •Age <18 years
- •Contraindications to contrast medium magnetic resonance imaging
研究组 & 干预措施
Evaluation of myocardial fibrosis
Echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent
干预措施: Evaluation of myocardial fibrosis (Diagnostic Test)
结局指标
主要结局
Evaluation of blood levels of Galectin-3 (Gal-3)
时间窗: 1 month
Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis
Evaluation of Enhanced Liver Fibrosis score (ELF)
时间窗: 1 month
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
Evaluation of CMR imaging marker of fibrosis
时间窗: 1 month
Evaluation at CMR of Myocardial T1 before and after contrast media infusion and Myocardial extracellular volume
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2)
时间窗: 1 month
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) gene as biomarker of fibrosis
次要结局
- 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)