Proof of Concept of Model Based Cardiovascular Prediction

Aortic Valve Disease Clinical Trial

Official title:

Proof of Concept of Model Based Cardiovascular Prediction

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02591940
• Other study ID #: Cardioproof
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 27, 2015
• Last updated: October 29, 2015
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: German Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Coarctation
• Aortic Valve Disease
• Cardiovascular Modeling
• Cardiovascular MRI
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

Procedure:
• Surgery or Treatment by Heart Catheter

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
German Heart Institute	Bambino Gesù Hospital and Research Institute, University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment		1 week up to 1 year	No
Primary	Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome)		1 week up to 1 year	No
Secondary	Calculated Vessle comliance		1 week up to 1 year	No
Secondary	Calculated External and Internal Heart Power		1 week up to 1 year	No
Secondary	Number of Participants with Aortic Coarctation with Arterial Hypertension		1 week up to 1 year	No