AI-CMR: Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Aortic valve disease-operation Surgery of the aortic valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. |
Procedure: Valvuloplasty,
Choice of type of intervention decided on a multidisciplinary conference
Other Names:
|
| Aortic valve disease-intervention Interventional treatment of the aortic valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. |
Procedure: Valvuloplasty,
Choice of type of intervention decided on a multidisciplinary conference
Other Names:
|
| Pulmonary valve disease-operation Surgery of the pulmonary valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment. |
Procedure: Valvuloplasty,
Choice of type of intervention decided on a multidisciplinary conference
Other Names:
|
| Pulmonary valve disease-intervention Interventional treatment of the pulmonary valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment |
Procedure: Valvuloplasty,
Choice of type of intervention decided on a multidisciplinary conference
Other Names:
|
Outcome Measures
Primary Outcome Measures
- CMR measures [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 [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)
Secondary Outcome Measures
- CMR derived flow measurements near metallic implants, stents [after 6 months, 1 year and up to 3 years after intervention]
Refined measurements of CMR derived 4D-flow measurements near metallic implants, stents
Eligibility Criteria
Criteria
Inclusion Criteria:
-
aortic valve disease
-
or pulmonary valve disease
-
clinical indication for valvular surgery
-
or clinical indication for valvular intervention
Exclusion Criteria:
-
contraindications for MRI
-
need of sedation or general anesthesia, unless there is a clinical indication for a CMR
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Queen Silvia Children'sHospital, Sahlgrenska University Hospital | Gothenburg | Sweden | 41560 |
Sponsors and Collaborators
- Sahlgrenska University Hospital, Sweden
Investigators
- Principal Investigator: Charlotte de Lange, MD, Assoc. Prof, Sahlgrenska University hospital, Queen Silvia Childrens' Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 277238