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Proof of Concept of Model Based Cardiovascular Prediction

Proof of Concept of Model Based Cardiovascular Prediction

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02591940
Enrollment
140
Registered
2015-10-30
Start date
2013-11-30
Completion date
2016-12-31
Last updated
2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cardiovascular modeling, aortic coarctation, aortic valve disease

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.

Interventions

PROCEDURESurgery or Treatment by Heart Catheter

Sponsors

Bambino Gesù Hospital and Research Institute
CollaboratorOTHER
University College, London
CollaboratorOTHER
German Heart Institute
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment1 week up to 1 year
Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome)1 week up to 1 year

Secondary

MeasureTime frame
Calculated Vessle comliance1 week up to 1 year
Calculated External and Internal Heart Power1 week up to 1 year
Number of Participants with Aortic Coarctation with Arterial Hypertension1 week up to 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 28, 2026