Clinical trial NCT02591940: Proof of Concept of Model Based Cardiovascular Prediction
Official title: Proof of Concept of Model Based Cardiovascular Prediction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Modeling
Aortic Coarctation
Aortic Valve Disease
Cardiovascular MRI
Keywords: cardiovascular modeling
aortic coarctation
aortic valve disease
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: Bambino Gesù Hospital and Research Institute
name: University College, London
First posted: 2015-10-30
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment
timeFrame: 1 week up to 1 year
measure: Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome)
timeFrame: 1 week up to 1 year
Secondary outcomes:
measure: Calculated Vessle comliance
timeFrame: 1 week up to 1 year
measure: Calculated External and Internal Heart Power
timeFrame: 1 week up to 1 year
measure: Number of Participants with Aortic Coarctation with Arterial Hypertension
timeFrame: 1 week up to 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Runte K, Brosien K, Schubert C, Nordmeyer J, Kramer P, Schubert S, Berger F, Hennemuth A, Kuehne T, Kelm M, Goubergrits L. Image-Based Computational Model Predicts Dobutamine-Induced Hemodynamic Changes in Patients With Aortic Coarctation. Circ Cardiovasc Imaging. 2021 Feb;14(2):e011523. doi: 10.1161/CIRCIMAGING.120.011523. Epub 2021 Feb 16.
citation: Nordmeyer S, Hellmeier F, Yevtushenko P, Kelm M, Lee CB, Lehmann D, Kropf S, Berger F, Falk V, Knosalla C, Kuehne T, Goubergrits L. Abnormal aortic flow profiles persist after aortic valve replacement in the majority of patients with aortic valve disease: how model-based personalized therapy planning could improve results. A pilot study approach. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):133-141. doi: 10.1093/ejcts/ezz149.
citation: Fernandes JF, Goubergrits L, Bruning J, Hellmeier F, Nordmeyer S, da Silva TF, Schubert S, Berger F, Kuehne T, Kelm M; CARDIOPROOF Consortium. Beyond Pressure Gradients: The Effects of Intervention on Heart Power in Aortic Coarctation. PLoS One. 2017 Jan 12;12(1):e0168487. doi: 10.1371/journal.pone.0168487. eCollection 2017.