Proof of Concept of Model Based Cardiovascular Prediction

Study Overview
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Brief Summary
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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.

Official Title
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Proof of Concept of Model Based Cardiovascular Prediction

Conditions
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Cardiovascular Modeling, Aortic Coarctation, Aortic Valve Disease, Cardiovascular MRI

Intervention / Treatment
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* Procedure: Surgery or Treatment by Heart Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: contraindications for MRI
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aortic Coarctation<br>interventional treatment in heart catheter (stenting/angioplasty) surgical repair of coarctation | Procedure: Surgery or Treatment by Heart Catheter<br> <br> |
| Aortic Valve Disease<br>surgical repair in aortic valve disease (reconstruction/valve replacement) | Procedure: Surgery or Treatment by Heart Catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment |  | 1 week up to 1 year | 
| Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome) |  | 1 week up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular modeling, aortic coarctation, aortic valve disease