Longitudinal Analysis of Myocardial Function by Speckle Tracking Echocardiography and Prediction of Delayed Toxic Cardiomyopathy Associated With Anthracycline Therapy in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Left Ventricle Global Longitudinal 2D strain (LVGLS) expressed in percentage and obtained from cardiac ultrasound cineloop of 2D 4,3 and 2 apical views analyzed by the Tomtec STE Software.
研究概览
简要总结
Longitudinal analysis of myocardial function using "Speckle Tracking Echocardiography" STE analysis and prediction of delayed toxic induced cardiomyopathy in young patients who received anthracycline therapy in childhood.
详细描述
Anthracycline therapy may have short-, medium- or long-term cardiac toxicity that impacts patient's life. The main recognized risk factors for delayed cardiotoxicity are cumulative anthracycline dose, female gender, association with mediastinal radiotherapy and young age at administration. Prediction of delayed cardiotoxicity in children population is still challenging.
The "Speckle Tracking Echocardiography" (STE) method, an innovative echocardiographic technique, analyses the myocardial displacement of natural acoustic markers via a software. The objective of the study is to analyze, in young patients who received anthracycline therapy in childhood, 5-years after their inclusion in the "Speckle Anthra" study and first STE results, the evolution of myocardial function using STE method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 27 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who were treated with anthracyclines for malignant disease between the ages of 0 and 18
- •Patient aged 11 to 27 years
- •Included in the "SpeckleAnthra" Study (NCT02893787)
- •Discontinued chemotherapy for more than 6 years
- •Patient in remission of malignant disease
- •Enrolled in a social security plan
- •Written informed consent from at least one legal representative for the minor patient/ Written informed consent for patients of legal age
排除标准
- •Onset of active malignancy or recurrence of malignancy after the "Speckle Anthra" study that required resumption of chemotherapy or mediastinal radiotherapy.
- •Chronic cardiac, pulmonary or muscular pathology of etiology other than secondary to anthracycline therapy
- •For adult patients: subject under guardianship or curators
- •CONTROL GROUP
- •Inclusion Criteria:
- •Control patient included in the "Speckle Control" study (NCT02056925)
- •Had a cardiological consultation with echocardiography performed for a banal reason (heart murmur test, cardiological symptoms) and whose result was normal
- •No chronic disease or long-term drug treatment
- •Exclusion Criteria:
- •Refusal to participate in the study by the patient and/or parents or legal guardian after receipt of the study's information and non-objection note.
结局指标
主要结局
Left Ventricle Global Longitudinal 2D strain (LVGLS) expressed in percentage and obtained from cardiac ultrasound cineloop of 2D 4,3 and 2 apical views analyzed by the Tomtec STE Software.
时间窗: 5 years
To compare the evolution at 5 years ("Anthra2" study timeframe) of LVGLS obtained by STE analysis on patients treated with anthracyclines in childhood and previously included in first "Speckle Anthra" study, with the normal evolution of this parameter with age in healthy matched volunteers.
次要结局
- Left Ventricle Ejection fraction (LVEF) by Simpson method (%)(The day of inclusion)
- Left ventricular myocardial dysfunction defined by LVEF < 55%(5 years)
- Death secondary to toxic cardiomyopathy(5 years)