Proof of Concept of Model Based Cardiovascular Prediction

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Disease; Aortic Coarctation; Cardiovascular Modeling; Cardiovascular MRI
• Intervention / Treatment: Procedure: Surgery or Treatment by Heart Catheter

• Study Type: Observational
• Enrollment (Anticipated): 140

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: German Heart Institute
• Collaborators: University College, London; Bambino Gesù Hospital and Research Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: PLoS One. 2017 Mar 23;12 (3):e0174838.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: aortic valve disease; cardiovascular modeling; aortic coarctation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Aortic Valve Disease; Aortic Coarctation
• Other Study ID Numbers: Cardioproof