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Proof of Concept of Model Based Cardiovascular Prediction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02591940
Recruitment Status : Unknown
Verified October 2015 by German Heart Institute.
Recruitment status was:  Enrolling by invitation
First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Bambino Gesù Hospital and Research Institute
University College, London
Information provided by (Responsible Party):
German Heart Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiovascular Modeling Aortic Coarctation Aortic Valve Disease Cardiovascular MRI Procedure: Surgery or Treatment by Heart Catheter

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Study Type : Observational
Estimated Enrollment : 140 participants
Time Perspective: Prospective
Official Title: Proof of Concept of Model Based Cardiovascular Prediction
Study Start Date : November 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment [ Time Frame: 1 week up to 1 year ]
  2. Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome) [ Time Frame: 1 week up to 1 year ]

Secondary Outcome Measures :
  1. Calculated Vessle comliance [ Time Frame: 1 week up to 1 year ]
  2. Calculated External and Internal Heart Power [ Time Frame: 1 week up to 1 year ]
  3. Number of Participants with Aortic Coarctation with Arterial Hypertension [ Time Frame: 1 week up to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with the need for surgical or interventional treatment with Aortic Coarctation, as well as patients with the need for aortic valve disease surgery, both according to current treatment guidelines.

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: German Heart Institute Identifier: NCT02591940    
Other Study ID Numbers: Cardioproof
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Keywords provided by German Heart Institute:
cardiovascular modeling
aortic coarctation
aortic valve disease
Additional relevant MeSH terms:
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Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities