Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease
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: Right-left heart catheterization in magnetic resonance imaging (MRI).
- Кому может быть актуально
- Состояния в реестре: Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction, Fontan Circulation. Базовые параметры: от 16 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of the Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease in Comparison to Right-left Heart Catheterization
Обзор
This study evaluates whether new flow parameters of the cardiac magnetic resonance imaging (MRI) allow evaluation of parameters for which usually invasive rigth-left heart catheterization are necessary. Patients who require a right-left heart catheterization will undergo the same day a heart catheterization in the MRI. Parameters obtained by MRI will be compared to the gold-standard, the right-left heart catheterization.
Подробное описание
Because of progress in early diagnosis, surgery, and medical treatment, almost all patients with congenital heart disease (CHD) survive nowadays into adulthood. However, most patients cannot be considered as cured as they are at high risk for complications like heart failure, valvopathies and pulmonary arterial hypertension (PAH). Treatment and diagnosis of these complications require often repetitive right-left heart catheterizations (RL-HC) for hemodynamic evaluations which are associated with a procedural risk, particularly in young patients in addition to a repeated radiation exposure. Advanced flow parameters obtained by the recently introduced Cardiac Magnetic Resonance (CMR) 4D flow technique promise non-invasive evaluation of hemodynamic parameters like pressure gradients and vascular resistance opening the door to partially replace RL-HC. However, 4D flow is limited by the need for ECG detection and cardiac movement during respiration. A new fully self-gated 5D CMR framework to cardiac and respiratory motion-resolved 3D flow imaging-5D flow aims to overcome these limitations. In addition, respiratory resolved flow determination is possible. As a result, 5D flow is a potentially powerful tool for the non-invasive assessment of hemodynamics like filling pressures and vascular resistance.
In the proposed study, patients will undergo a CMR-guided RL-HC in addition to a clinically indicated RL-HC.
As CMR is the gold standard for non-invasive flow determination, the combination of CMR-derived flow and RL-HC-derived pressures allows a precise evaluation of vascular resistance as it overcomes the limitations of the classic invasive methods for determination of cardiac output like the Fick or thermodilution techniques and the radiation exposure. This is particularly interesting in CHD patients in whom e.g. pulmonary resistance can differ in both lungs. For this reason, CMR guided heart catheterization (iCMR) is therefore increasingly incorporated in the routine use in different centers.
This study evaluates the feasibility of the determination of the relationship between noninvasive advanced 5D flow parameters and invasive catheter-derived vascular and ventricular hemodynamic parameters in PH/PAH and CHD patients. This will help to improve diagnosis and knowledge of the pathophysiological mechanisms in these complex patients.
All patients will undergo a clinical indicated standard RL-HC. In Fontan patients, a liver biopsy will be performed which is part of the routine follow-up for these patients. The participants are transferred to the interventional CMR suite. A RL-HC will be performed under CMR control. Invasive pressure measurements will be performed at predefined positions. After the RL-HC, the 5D flow will be obtained as well as a standard cardiac magnetic resonance imaging for determination of ventricular function and standard 2D and 4D flow.
Вмешательства
- Диагностический тест Right-left heart catheterization in magnetic resonance imaging (MRI)
Right-left heart catheterization in MRI
Первичные конечные точки
- Vorticity (s-1) [Срок оценки: Periprocedural]
- Helicity (m⁴/s²) [Срок оценки: Periprocedural]
- Pressure maps (mmHg) [Срок оценки: Periprocedural]
- Kinetic energy (KE) (J) and its loss (EL, J/m3) [Срок оценки: Periprocedural]
Критерии участия
Критерии включения
- Referral for work-up of known or suspected pulmonary hypertension (PH), RVOT pathology, or Fontan-type repair with a clinical indication for RL-HC.
- Ability to provide informed consent or have consent provided by a legal representative (and assent for minors aged 16-18).
- Male or female participants of all ethnicities and sociodemographic backgrounds
Критерии исключения
- Participants unable to comply with study procedures due to language barriers, cognitive or psychological limitations, or lack of legal consent.
- Patients with contraindications to RL-HC or CMR.
- Patients not having a clinical indication to RL-HC.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Швейцария · 1 центр
- Lausanne University Hospital — Lausanne
Идентификаторы
NCT: NCT07742046 · 2025-01908 · 320030-231872