Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease (AI-CMR)

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:

• [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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Valve Disease; Magnetic Resonance Imaging; Child, Only; Risk Stratification; Pulmonary Valve Disease
• Intervention / Treatment: Procedure: Valvuloplasty,

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 Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41560
    • Queen Silvia Children'sHospital, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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: surgical valvular repair
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: surgical valvular repair
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: surgical valvular repair
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: surgical valvular repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	Before and after 6 months, 1 year and up to 3 years after intervention or surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CMR derived flow measurements near metallic implants, stents	Refined measurements of CMR derived 4D-flow measurements near metallic implants, stents	after 6 months, 1 year and up to 3 years after intervention

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Investigators: Principal Investigator: Charlotte de Lange, MD, Assoc. Prof, Sahlgrenska University hospital, Queen Silvia Childrens' Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Valve Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Aortic Valve Disease; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 277238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No