Cardiovascular ModelingNCT02591940
Proof of Concept of Model Based Cardiovascular Prediction
An observational study of Cardiovascular Modeling and Aortic Coarctation, run by German Heart Institute.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Modeling, Aortic Coarctation, Aortic Valve Disease
- What is being tested?
- Surgery or Treatment by Heart Catheter
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- contraindications for MRI
About this study
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.
- Being tested
- Surgery or Treatment by Heart Catheter
- Keywords
- cardiovascular modeling, aortic coarctation, aortic valve disease
- Medical subject headings
- Aortic Coarctation, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery or Treatment by Heart CatheterProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Aortic Coarctation | interventional treatment in heart catheter (stenting/angioplasty) surgical repair of coarctation Receives: Procedure: Surgery or Treatment by Heart Catheter | |
| Aortic Valve Disease | surgical repair in aortic valve disease (reconstruction/valve replacement) Receives: Procedure: Surgery or Treatment by Heart Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment
Measured: 1 week up to 1 year
Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome)
Measured: 1 week up to 1 year
Secondary outcomes (3)
Calculated Vessle comliance
Measured: 1 week up to 1 year
Calculated External and Internal Heart Power
Measured: 1 week up to 1 year
Number of Participants with Aortic Coarctation with Arterial Hypertension
Measured: 1 week up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular ModelingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bambino Gesù Hospital and Research Institute, University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591940
- Sponsor's protocol ID
- Cardioproof
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fierley L, Versnjak J, Gabel G, Kramer P, Goubergrits L, Berger F, Montavon G, Kuehne T, Kelm M. Prediction of hypertension and restenosis under guideline-directed management in aortic coarctation: development and validation of machine-learning models. EClinicalMedicine. 2026 Jun 26;97:104041. doi: 10.1016/j.eclinm.2026.104041. eCollection 2026 Jul.
PubMed 42389462Runte 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.
PubMed 33591212Nordmeyer 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.
PubMed 31131388Fernandes 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.
PubMed 28081162
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept of Model Based Cardiovascular Prediction
- ClinicalTrials.gov ID
- NCT02591940
- Acronym / sponsor ID
- Cardioproof
- Keywords
- cardiovascular modeling, aortic coarctation, aortic valve disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Bambino Gesù Hospital and Research Institute, University College, London
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic Coarctation | – | Procedure: Surgery or Treatment by Heart Catheterinterventional treatment in heart catheter (stenting/angioplasty) surgical repair of coarctation |
| Aortic Valve Disease | – | Procedure: Surgery or Treatment by Heart Cathetersurgical repair in aortic valve disease (reconstruction/valve replacement) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients with the need for surgical or interventional treatment with Aortic Coarctation
- patients with the need for aortic valve disease surgery
Key exclusion criteria (1 listed)
- contraindications for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery or Treatment by Heart Catheter | Procedure or surgery | Aortic Coarctation, Aortic Valve Disease |
Primary outcome
Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment
Time frame: 1 week up to 1 year
Predicted (simulated) vs. real haemodynamic 4D flow profile (treatment outcome)
Time frame: 1 week up to 1 year
3 secondary outcomes
Calculated Vessle comliance
Time frame: 1 week up to 1 year
Calculated External and Internal Heart Power
Time frame: 1 week up to 1 year
Number of Participants with Aortic Coarctation with Arterial Hypertension
Time frame: 1 week up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Derived from this study: PubMed 42389462Fierley L, Versnjak J, Gabel G, Kramer P, Goubergrits L, Berger F, Montavon G, Kuehne T, Kelm M. Prediction of hypertension and restenosis under guideline-directed management in aortic coarctation: development and validation of machine-learning models. EClinicalMedicine. 2026 Jun 26;97:104041. doi: 10.1016/j.eclinm.2026.104041. eCollection 2026 Jul.
- Derived from this study: PubMed 33591212Runte 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.
- Derived from this study: PubMed 31131388Nordmeyer 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.
- Derived from this study: PubMed 28081162Fernandes 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.
Related trials for Cardiovascular Modeling
Not yet recruitingObservational study
Continuous Blood Pressure Variability and Small Vessel Disease in Acute Ischemic Stroke
Ischemic Stroke, Acute, Blood Pressure Variability
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
RecruitingObservational study
A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
RecruitingObservational study
Modeling Mortality in Duchenne Muscular Dystrophy Cardiomyopathy: Identification of Surrogate Outcome Measures for DMD Drug Trials
Duchenne Muscular Dystrophy (DMD), Cardiomyopathy
Not yet recruitingObservational study
Out-of-hospital Cardiac Arrest Epidemiology and Outcomes in Western Lithuania 2022-2028
Out-of-hospital Cardiac Arrest (OHCA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Modeling and Aortic Coarctation, run by German Heart Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative Cost effectiveness between regular treatment vs. simulated alternative treatment (time frame: 1 week up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591940, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.