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Набор по приглашению NCT05979870

Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease

Наблюдательное Aortic Valve Disease Pulmonary Valve Disease Child, Only Magnetic Resonance Imaging

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Valvuloplasty,.
Кому может быть актуально
Состояния в реестре: Aortic Valve Disease, Pulmonary Valve Disease, Child, Only, Magnetic Resonance Imaging. Базовые параметры: 1 Week — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease -Improving the Assessment, Monitoring and Prediction in Children

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура Valvuloplasty,
    Choice of type of intervention decided on a multidisciplinary conference

Первичные конечные точки

  • CMR measures [Срок оценки: Before and after 6 months, 1 year and up to 3 years after intervention or surgery]
  • Physical capacity [Срок оценки: Before and after 6 months, 1 year and up to 3 years after intervention or surgery]
Вторичные конечные точки (1)
  • CMR derived flow measurements near metallic implants, stents [Срок оценки: after 6 months, 1 year and up to 3 years after intervention]

Критерии участия

Критерии включения

  • aortic valve disease
  • or pulmonary valve disease
  • clinical indication for valvular surgery
  • or clinical indication for valvular intervention

Критерии исключения

  • contraindications for MRI
  • need of sedation or general anesthesia, unless there is a clinical indication for a CMR

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 1 центр
  • Queen Silvia Children'sHospital, Sahlgrenska University Hospital — Gothenburg

Идентификаторы

NCT: NCT05979870 · 277238

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗