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Идёт набор NCT06912477

Endothelial Dysfunction for Prognosis In Patients With preeClampSia

Наблюдательное Preeclampsia (PE) Hypertensive Disorder of Pregnancy

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: Hyperspectral imaging, Further markers of endothelial dysfunction.
Кому может быть актуально
Состояния в реестре: Preeclampsia (PE), Hypertensive Disorder of Pregnancy. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Systematic Evaluation of Endothelial Dysfunction as a Prognostic Marker for Outcomes in Women With Preeclampsia

Обзор

Preeclampsia is a pregnancy-specific hypertensive disorder and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial and microcirculatory dysfunction mediate systemic preeclampsia-related organ dysfunctions. Changes in endothelial and vascular function in preeclampsia have been demonstrated through reduced flow-mediated vasodilation as a result of reduced availability of nitric oxide, which potentially persists up to several years postpartum. Hyperspectral imaging is a new innovative technology that allows to assess the peripheral microcirculation and perfusion non-invasively and contactless, but has never been evaluated in the context of preeclampsia before. This EPICS project (Endothelial dysfunction for Prognosis In patients with preeClampSia) is a prospective observational study and aims to investigate hyperspectral imaging as a new potential diagnostic and prognostic marker in preeclampsia.

Подробное описание

Preeclampsia is defined as hypertension combined with features of multi-organ dysfunction and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial dysfunction is a key driver in the pathophysiology of preeclampsia mediating the systemic complications of this multi-organ disease. Changes in endothelial and vascular function in preeclampsia have been observed through reduced flow-mediated vasodilation, which occurs due to diminished nitric oxide availability and may persist for years after childbirth. Although symptoms of preeclampsia often resolve spontaneously after delivery, affected women will face a significantly increased risk of long-term cardiovascular complications. Thus, preeclampsia is viewed as an individual female-specific cardiovascular risk factor.

Beyond this background, hyperspectral imaging as an assessment of peripheral microcirculation and tissue perfusion appears to be a suitable method. Hyperspectral imaging is an innovative technique that visualizes hemodynamic changes by displaying the oxygen saturation of hemoglobin in the capillary system, the distribution of hemoglobin in the tissue, and the relative tissue water content. Hyperspectral imaging has not yet been studied in obstetrics or in the context of preeclampsia before. Given the well-documented microcirculatory disturbances associated with preeclampsia, the investigators hypothesize hyperspectral analysis as a valuable tool to bridge a diagnostic gap that might be useful to tailor individualized obstetric care of patients with preeclampsia.

Recently the "Endothelial Activation and Stress Index" (EASIX) was evaluated as prognostic marker in preeclampsia by the investigator group. EASIX is based on lactate dehydrogenase, platelets, and creatinine and was originally developed as simple score to predict endothelial-related complications after allogenic stem cell transplantation. However, the exact relationship of EASIX to endothelial cell biology and microcirculation requires further clarification. The investigators hypothesize that a reduced peripheral microcirculation will mediate direct interactions of platelets with endothelial cells, resulting in cellular damage (increased LDH), loss of platelets due to activation and microembolism, and lead to kidney damage.

The EPICS study (Endothelial dysfunction for Prognosis In patients with preeClampSia) is the first prospective study to investigate hyperspectral imaging in women with preeclampsia. The aim of this study is to evaluate whether and how changes in microcirculation in women with preeclampsia can be detected with hyperspectral imaging compared to women with pregnancy-induced hypertension, normotensive pregnant women and non-pregnant controls and whether microcirculatory perfusion quality is associated with other biochemical markers such as EASIX or markers of endothelial dysfunction. Furthermore, the EPICS study aims to evaluate the predictive performance of hyperspectral imaging with or without combination of other biochemical markers for adverse maternal and perinatal outcomes and the remaining time until delivery in patients with preeclampsia.

Вмешательства

  • Диагностический тест Hyperspectral imaging
    Hyperspectral imaging will be performed at study inclusion and will be repeated longitudinally every 1-2 days until delivery and on the first and second day after delivery. After a baseline measurement, a blood pressure cuff is inflated on the upper arm to 50 mmHg above the systolic blood pressure for 5 minutes, and then the hyperspectral imaging measurement is repeated. Blood samples are collected at study inclusion and on the first and second day after delivery and are processed within the De
  • Диагностический тест Further markers of endothelial dysfunction
    At study inclusion: 1. blood samples will be collected for the measurement of EASIX and cardiac/endothelial markers; 2. sublingual in vivo microscopy will be performed (requires about 20 minutes and can be compared to a sublingual temperature measurement); 3. Doppler ultrasound will be performed to evaluate uterine and ophthalmic arteries. Blood samples will also be collected at the first and second day after delivery.

Первичные конечные точки

  • Time Until Delivery [Срок оценки: observation period until 6 months after delivery]
Вторичные конечные точки (6)
  • maternal adverse event [Срок оценки: observation period until 6 months after delivery]
  • perinatal adverse event [Срок оценки: observation period until 6 months after delivery]
  • maternal cardiovascular outcome: persistence of hypertension [Срок оценки: observation period until 6 months after delivery]
  • maternal cardiovascular outcome: blood pressure [Срок оценки: observation period until 6 months after delivery]
  • maternal cardiovascular outcome: antihypertensive medication [Срок оценки: observation period until 6 months after delivery]
  • maternal cardiovascular outcome: readmission [Срок оценки: observation period until 6 months after delivery]

Критерии участия

Критерии включения

  • singleton pregnancies
  • Age ≥ 18 years
  • Patient's ability to provide consent
  • written informed consent

Критерии исключения

  • Lack of consent
  • Language barrier
  • Dark to very dark skin type
  • Severe fetal chromosomal/genetic/structural anomalies
  • Laboratory changes in LDH, creatinine, or platelets due to other causes (e.g., isolated thrombocytopenia, e.g., immune thrombocytopenia, carcinoma)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Heidelberg University Hospital, Department of Gynecology and Obstetrics — Heidelberg

Идентификаторы

NCT: NCT06912477 · S-457/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗