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临床试验/NCT02934971
NCT02934971Unknown不适用

Optimized Multi-modality Machine Learning Approach During Cardio-toxic Chemotherapy to Predict Arising Heart Failure

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
470
试验地点
1
主要终点
Change in LVEF from baseline to one year, as determined by MRI as gold standard according to random study group allocation

研究概览

简要总结

The present project will develop an automated machine learning approach using multi-modality data (imaging, laboratory, electrocardiography and questionnaire) to increase the understanding and prediction of arising heart failure in patients scheduled for cardio-toxic chemotherapy. This algorithmus will be developed by the technical cooperation partner at Technion, the institut for biomedical engineering in Haifa, Israel.

详细描述

The present project will develop an automated machine learning approach using multi-modality data (imaging, laboratory, electrocardiography and questionnaire) to increase the understanding and prediction of arising heart failure in patients scheduled for cardio-toxic chemotherapy. This algorithmus will be developed by the technical cooperation partner Prof. Adam who leads the Technion, the institut for biomedical engineering.

Specific aims:

  1. To collect all achievable data from patients scheduled for cardiotoxic chemotherapy at baseline, up to 6 months after ending therapy - regarding imaging (MRI, echocardiography with conventional and strain parameter), electrocardiography, biomedical markers (to define the function of liver, kidney, heart and hematopoietic bone marrow), clinical parameter and quality of life questionnaire:
  2. To optimize and evaluate a robust machine learning approach that integrate and assess all these data to detect early myocardial damage and to identify an optimal parameter (single or in combination) for prediction of subclinical left ventricular (LV) dysfunction (stage 1 of the current study).
  3. To perform a clinical study (stage 2 of the current study) of chemotherapy patients, and to identify subclinical LV dysfunction, which will be used to guide cardioprotective therapy using the new machine learning approach in comparison to the actual standard procedure using only echocardiographic left ventricular ejection fraction (LVEF).

The purpose of this study is to evaluate and optimize a machine learning approach to combine and integrate data from different imaging modalities with laboratory, electrocardiography and questionnaire information to define the value of all these parameter in patient management, by identification of subclinical LV dysfunction, which will be used to guide cardioprotective therapy in comparison to a standard approach using only conventional echocardiographic parameters.

MRI, conventional echocardiographic parameters and echocardiographic myocardial deformation imaging are employing different modalities and approaches to obtain insight into myocardial tissue and deformation. We hypothesize that a new and optimized automated algorithm using these modalities and integrating laboratory, electrocardiography and questionnaire information will improve the detection of early LV dysfunctions, and will bring new insight to the potential response of chemo patients to cardiotoxic therapy. We expect that this algorithm leads to the use of adjunctive therapy that will limit the development of LV dysfunction, interruptions of chemotherapy and development of heart failure in follow-up and thus will reduce morbidity and costs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients Patients scheduled for chemotherapy at increased risk of cardiotoxicity (regarding 200 Chemo patients in stage 1 study and 70 Chemo patients in stage 2 study):
  • use of anthracycline with
  • trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR
  • tyrosine kinase inhibitors (eg sunitinib) OR
  • cumulative anthracycline dose >450g/m2 of doxorubicin, or equivalent other anthracycline cumulative dose (eg for epirubicine >900g/m2) OR
  • -increased risk of heart failure (HF) (age >65y, type 2 diabetes mellitus, hypertension, previous cardiac injury eg. myocardial infarction)
  • Female aged > 18 years
  • Written informed consent prior to study participation
  • The subject is willing and able to follow the procedures outlined in the protocol The department of gynecology at the RWTH University hospital will inform the principal investigator about these patients.

排除标准

  • Valvular stenosis or regurgitation of >moderate severity
  • History of previous heart failure (baseline New York Heart Association - NYHA >2)
  • Inability to acquire interpretable images (identified from baseline echo)
  • Contraindication to perform a MRI
  • Oncologic (or other) life expectancy <12 months
  • Pregnant and lactating females
  • Patient has been committed to an institution by legal or regulatory order
  • Participation in a parallel interventional clinical trial
  • The subject received an investigational drug within 30 days prior to inclusion into this study
  • Relevant renal insufficiency

结局指标

主要结局

Change in LVEF from baseline to one year, as determined by MRI as gold standard according to random study group allocation

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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