Aortic Valve DiseaseAI-CMRNCT05979870
Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease
An observational study of Aortic Valve Disease and Pulmonary Valve Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional… Read more about this study
- Who is it for?
- Ages 1 week to 18 years
- Conditions the study is for
- Aortic Valve Disease, Pulmonary Valve Disease, Child, Only
- What is being tested?
- Valvuloplasty,
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 week to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Childen aged 0-18 years old with aortic or pulmonary valve disease in need of treatment admitted to the Paediatric Heart Centre, Queen Silvia Childrens' Hospital, Gothenburg Sweden. Patients will be invited to participate in the study after a multidisciplinary conference on decision of treatment
Who may be able to join
- aortic valve disease
- or pulmonary valve disease
- clinical indication for valvular surgery
- or clinical indication for valvular intervention
Who cannot join
- contraindications for MRI
- need of sedation or general anesthesia, unless there is a clinical indication for a CMR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Queen Silvia Children'sHospital, Sahlgrenska University Hospital
Gothenburg, Gothenburg, 41560
About this study
Official title: Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease -Improving the Assessment, Monitoring and Prediction in Children
The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional CMR estimates.
The main question[s] it aims to answer are:
Read more
- [question 1]To evaluate risk stratification for surgery and intervention of the aortic- and pulmonary valve
- [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes before and after interventional or surgical treatment of the aortic- and pulmonary valve at short and long term.
Participants will undergo cardiac MRI before and after interventional or surgical treatment of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control group established at the department in another study.
Read the detailed description
Background:
An increasing number of children with complex congenital heart disease (CHD) are today treated and survive into adulthood. They are in need of a lifelong surveillance for cardiovascular complications and an individualised treatment.
In paediatric aortic and pulmonary valve disease, the long-term complications are related to valvular dysfunction with myocardial fibrosis and ventricular dysfunction as a result of longstanding volume or pressure overload. Many patients will need surgery or interventional treatment already in childhood, where the optimal timing of the intervention is crucial, since early treatment may prevent irreversible injury to the heart.
Moreover, to enable detection of recurrent or new problems early, a long-term diagnostic follow-up is needed where cardiovascular magnetic resonance (CMR) has become important for a serial reproducible assessment of morphology, function and recently advanced methods for flow and tissue characterisation. Still the the clinical decision of the perfect time-point and type of treatment for a child, may be difficult in many cases, and better measures are needed.
Aim:
This project will investigate children with aortic and pulmonary valve disease treated or untreated longitudinally using established CMR measures with additional newly developed, promising, highly refined and clinically applicable quantitative imaging biomarkers, as compared to the conventional CMR estimates. Investigators aim to evaluate risk stratification and investigate the haemodynamic and morphological changes as well as physical capacity before and after interventional or surgical treatment at short and long term.
CMR will be analysed for established imaging biomarkers as well as the potential value of new data-driven computer tools searching for new information in the CMR images i.e. shape/texture analysis of tissue change, regional haemodynamics, blood flow in relation to metallic implants and evaluation of myocardial deformation over time.
CMR measures will be compared to data from echocardiography, catheterization and serological markers.
Clinical importance:
If the new refined CMR biomarkers can reveal improved disease characterisation, they may reveal feasible in aiding the clinical decision making to optimise timing of intervention and predicting long term complications. This could contribute to individualise the treatment and improve health in children with CHD. The study may lead to improved patient care and use of socio-economical resources.
- Conditions
- Aortic Valve Disease, Pulmonary Valve Disease, Child, Only, Magnetic Resonance Imaging, Risk Stratification
- Being tested
- Valvuloplasty,
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valvuloplasty,Procedure or surgery
Also called surgical valvular repair
Choice of type of intervention decided on a multidisciplinary conference
| Study group | Role | What they receive |
|---|---|---|
| Aortic valve disease-operation | Surgery of the aortic valve:
Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. Receives: Procedure: Valvuloplasty, | |
| Aortic valve disease-intervention | Interventional treatment of the aortic valve:
Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. Receives: Procedure: Valvuloplasty, | |
| Pulmonary valve disease-operation | Surgery of the pulmonary valve:
Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. Receives: Procedure: Valvuloplasty, | |
| Pulmonary valve disease-intervention | Interventional treatment of the pulmonary valve:
Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment Receives: Procedure: Valvuloplasty, |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMR measures
Measurement by CMR of changes in ventricular function, remodelling, tissue characterisation and advanced four dimensional flow (4D-flow) measurements after surgery or intervention
Measured: Before and after 6 months, 1 year and up to 3 years after intervention or surgery
Physical capacity
Measurement of physical capacity after surgery or intervention, by cardiopulmonary exercise testing (CPET)
Measured: Before and after 6 months, 1 year and up to 3 years after intervention or surgery
Secondary outcomes (1)
CMR derived flow measurements near metallic implants, stents
Refined measurements of CMR derived 4D-flow measurements near metallic implants, stents
Measured: after 6 months, 1 year and up to 3 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Oct 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte de Lange, Sahlgrenska University Hospital
- Investigators
- Charlotte de Lange, MD, Assoc. Prof, Principal investigator, Sahlgrenska University hospital, Queen Silvia Childrens' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979870
- Sponsor's protocol ID
- 277238
- Acronym
- AI-CMR
- Status last verified
- May 2025
- First submitted
- 31 Jul 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease -Improving the Assessment, Monitoring and Prediction in Children
- ClinicalTrials.gov ID
- NCT05979870
- Acronym / sponsor ID
- AI-CMR / 277238
- Conditions
- Aortic Valve Disease, Pulmonary Valve Disease, Child, Only, Magnetic Resonance Imaging, Risk Stratification
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Aug 2023 (actual)
- 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.
The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional CMR estimates.
The main question[s] it aims to answer are:
- [question 1]To evaluate risk stratification for surgery and intervention of the aortic- and pulmonary valve
- [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes before and after interventional or surgical treatment of the aortic- and pulmonary valve at short and long term.
Participants will undergo cardiac MRI before and after interventional or surgical treatment of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control group established at the department in another study.
Detailed description
Background:
An increasing number of children with complex congenital heart disease (CHD) are today treated and survive into adulthood. They are in need of a lifelong surveillance for cardiovascular complications and an individualised treatment.
In paediatric aortic and pulmonary valve disease, the long-term complications are related to valvular dysfunction with myocardial fibrosis and ventricular dysfunction as a result of longstanding volume or pressure overload. Many patients will need surgery or interventional treatment already in childhood, where the optimal timing of the intervention is crucial, since early treatment may prevent irreversible injury to the heart.
Moreover, to enable detection of recurrent or new problems early, a long-term diagnostic follow-up is needed where cardiovascular magnetic resonance (CMR) has become important for a serial reproducible assessment of morphology, function and recently advanced methods for flow and tissue characterisation. Still the the clinical decision of the perfect time-point and type of treatment for a child, may be difficult in many cases, and better measures are needed.
Aim:
This project will investigate children with aortic and pulmonary valve disease treated or untreated longitudinally using established CMR measures with additional newly developed, promising, highly refined and clinically applicable quantitative imaging biomarkers, as compared to the conventional CMR estimates. Investigators aim to evaluate risk stratification and investigate the haemodynamic and morphological changes as well as physical capacity before and after interventional or surgical treatment at short and long term.
CMR will be analysed for established imaging biomarkers as well as the potential value of new data-driven computer tools searching for new information in the CMR images i.e. shape/texture analysis of tissue change, regional haemodynamics, blood flow in relation to metallic implants and evaluation of myocardial deformation over time.
CMR measures will be compared to data from echocardiography, catheterization and serological markers.
Clinical importance:
If the new refined CMR biomarkers can reveal improved disease characterisation, they may reveal feasible in aiding the clinical decision making to optimise timing of intervention and predicting long term complications. This could contribute to individualise the treatment and improve health in children with CHD. The study may lead to improved patient care and use of socio-economical resources.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aortic valve disease-operation | – | Procedure: Valvuloplasty,Surgery of the aortic valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. |
| Aortic valve disease-intervention | – | Procedure: Valvuloplasty,Interventional treatment of the aortic valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. |
| Pulmonary valve disease-operation | – | Procedure: Valvuloplasty,Surgery of the pulmonary valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. |
| Pulmonary valve disease-intervention | – | Procedure: Valvuloplasty,Interventional treatment of the pulmonary valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment |
Who may qualify
- Ages
- 1 week to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Childen aged 0-18 years old with aortic or pulmonary valve disease in need of treatment admitted to the Paediatric Heart Centre, Queen Silvia Childrens' Hospital, Gothenburg Sweden. Patients will be invited to participate in the study after a multidisciplinary conference on decision of treatment
Key inclusion criteria (4 listed)
- aortic valve disease
- or pulmonary valve disease
- clinical indication for valvular surgery
- or clinical indication for valvular intervention
Key exclusion criteria (2 listed)
- contraindications for MRI
- need of sedation or general anesthesia, unless there is a clinical indication for a CMR
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 |
|---|---|---|
| Valvuloplasty,Also: surgical valvular repairChoice of type of intervention decided on a multidisciplinary conference | Procedure or surgery | Aortic valve disease-intervention, Aortic valve disease-operation, Pulmonary valve disease-intervention, Pulmonary valve disease-operation |
Primary outcome
CMR measures
Time frame: Before and after 6 months, 1 year and up to 3 years after intervention or surgery
Measurement by CMR of changes in ventricular function, remodelling, tissue characterisation and advanced four dimensional flow (4D-flow) measurements after surgery or intervention
Physical capacity
Time frame: Before and after 6 months, 1 year and up to 3 years after intervention or surgery
Measurement of physical capacity after surgery or intervention, by cardiopulmonary exercise testing (CPET)
1 secondary outcome
CMR derived flow measurements near metallic implants, stents
Time frame: after 6 months, 1 year and up to 3 years after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Charlotte de Lange, MD, Assoc. Prof principal investigator
Sahlgrenska University hospital, Queen Silvia Childrens' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Pulmonary Valve Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
CMR measures (time frame: Before and after 6 months, 1 year and up to 3 years after intervention or surgery). 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?
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 15 May 2025.