跳至主要内容
临床试验/NCT02591940
NCT02591940Unknown不适用

Proof of Concept of Model Based Cardiovascular Prediction

German Heart Institute0 个研究点目标入组 140 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
140
主要终点
Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment

研究概览

简要总结

CARDIOPROOF is a proof-of-concept project that consolidates the outcomes of previous virtual physiological human (VPH) projects and checks the applicability and effectiveness of available predictive modelling and simulation tools, validating them in interrelated clinical trials conducted in three European centres of excellence in cardiac treatment (from Germany, Italy and the UK). CARDIOPROOF focuses on patients with aortic valve disease and aortic coarctation, which, if left untreated, can ensue irreversible heart failure. As a result treatment becomes mandatory, but optimum timing and the best type of treatment still remain difficult to determine. With more than 50.000 interventions per year within the EU, the diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present clinical guidelines are highly complex and rely mostly on imaging diagnostics and clinical parameters, without benefiting, as yet, from patient-specific disease modelling based prediction. CARDIOPROOF goes beyond the current state of the art by conducting validation trials aimed at covering and comparing the complete spectrum of cardiovascular treatment, predicting the evolution of the disease and the immediate and mid-term outcome of treatment. Operational clustering is going to provide a seamless clinical solution that applies different modeling methods to realize the potential of personalised medicine taking into account user-friendliness as a key component of clinical usability. CARDIOPROOF's goal is to provide first-hand data on comparative cost-effectiveness and clinical efficacy of the most advanced VPH approaches compared to conventional diagnostics and treatment algorithms, thus accelerating the deployment of VPH methods in clinical environments, and bring to maturity holistic patient-specific computer-based predictive models and simulations.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •patients with the need for surgical or interventional treatment with Aortic Coarctation
  • •patients with the need for aortic valve disease surgery
  • •both according to current treatment guidelines

排除标准

  • •contraindications for MRI

结局指标

主要结局

Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment

时间窗: 1 week up to 1 year

Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome)

时间窗: 1 week up to 1 year

次要结局

  • Calculated Vessle comliance(1 week up to 1 year)
  • Calculated External and Internal Heart Power(1 week up to 1 year)
  • Number of Participants with Aortic Coarctation with Arterial Hypertension(1 week up to 1 year)

研究者

发起方
German Heart Institute
申办方类型
Other
责任方
Sponsor

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