Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography
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: Electrocardiogram, Transthoracic echocardiogram, Right heart catheter.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Hypertension. Базовые параметры: от 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
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension. The main questions it aims to answer are: Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers?
Подробное описание
Pulmonary Hypertension (PH) is a condition caused by high blood pressure in the blood vessels that carry blood to the lungs. It can cause severe breathlessness and failure of the right side of the heart. Sadly it is often fatal.
PH can be caused by a number of different conditions and life expectancy varies with the underlying cause, ranging from months to years. For some subtypes of PH, effective treatments exist which can significantly improve life expectancy and quality of life. Accurate tools for the assessment of PH are therefore essential, so that we can better understand and predict life expectancy and so that life-saving medications can be started earlier.
Once doctors suspect that somebody has PH, they refer them to a specialist PH centre for assessment and a procedure called right heart catheterisation (RHC), which will confirm the diagnosis. However, evidence for the suspicion of PH is frequently overlooked, leading to an average delay to diagnosis from onset of symptoms of two years. This late presentation negatively impacts survival for these patients and prevents them promptly starting the effective treatments which are available.
An electrocardiogram (ECG) is a recording of the heart's electrical signals, printed in waveforms. It is a painless, low-cost, and readily-available test used in PH assessment.
Echocardiography (echo) is a quick, safe and well-tolerated test often requested to investigate breathless patients and can provide useful information about the suspicion of PH. Echo has however been shown to lack accuracy in milder forms of the disease. It has been hypothesised that subtle markers of right ventricular function by echo, such as free wall strain (RVFWS) begin to deteriorate before the more established findings.
A large, cross-population study of ECG features and echo markers such as RVFWS both in isolation and in combination, in patients referred for PH assessment may help identify these markers, and improve detection of the disease.
Вмешательства
- Диагностический тест Electrocardiogram
Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart - Диагностический тест Transthoracic echocardiogram
Non-invasive 2 \& 3 dimensional imaging of the heart using ultrasound - Диагностический тест Right heart catheter
Minimally invasive cardiac chamber pressure measurement using balloon catheterisation
Первичные конечные точки
- Distinguish between patients with and without pulmonary hypertension [Срок оценки: 2 years]
- Distinguish between patients with pre-capillary hypertension and post-capillary hypertension [Срок оценки: 2 years]
Вторичные конечные точки (2)
- Assess the impact of the severity of pulmonary hypertension [Срок оценки: 2 years]
- Assess the impact of additional electrocardiogram markers on existing pulmonary hypertension probability stratification [Срок оценки: 2 years]
Критерии участия
Критерии включения
- Patients 18+ who have undergone TTE, ECG and RHC as part of their clinical care
Критерии исключения
- Patients <18 years old
- Known or suspected congenital heart disease
- Patient has opted-out of allowing their data to be used for research and planning (via the national data opt-out choice in England, or equivalent data protection scheme in Scotland)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Великобритания · 5 центров
- Royal United Hospital NHS Foundation Trust — Bath
- Golden Jubilee Hospital — Glasgow
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield
- Royal Papworth Hospital — Cambridge
- Royal Free NHS Foundation Trust — London
Идентификаторы
NCT: NCT06386185 · DRAPE