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Идёт набор NCT06258109

Risk of Recurrent CeAD After Pregnancy

Наблюдательное Cervical Artery Dissection Pregnancy Complications

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cervical Artery Dissection, Pregnancy Complications. 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
США, Аргентина, Австрия, Финляндия, Германия +4
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy (LONG-RECAP Study)

Обзор

Primary objective: To determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data. Methods: Multicentric, observational case-control study based on pooled individual patient data from several stroke centers. Primary endpoint: Primary composite outcome measure includes the following outcomes: (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death.

Подробное описание

Background: Cervical artery dissection (CeAD) is a leading cause of stroke in women of childbearing age. Among the population with an initial CeAD, about 9% show a recurrence event (a range from 0 to 25% has been reported). Recurrence of CeAD can occur for several years after the initial event. CeAD has been shown to occur in association with pregnancy, and the postpartum period, yet it remains unclear whether pregnancy increases the risk of recurrence or delayed stroke. Previous studies on this subject are either based on small sample sizes or lack long-term data.

Objective: The investigators want to determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.

Furthermore, it will be investigated whether the mode of delivery affects recurrence and if dissections occurred during a particular phase of a woman's reproductive process. The investigators will also investigate if women actively decided against another pregnancy due to the initial CeAD.

Methods: This study will be a multicenter, exploratory case-control study using pooled individual patient data from several stroke centers. The data will be obtained through review of medical records and patient interviews. The study will include all women with any prior CeAD who have had long-term follow-up (at least 6 months, with no upper limit), including information about pregnancy and recurrence of CeAD.

Primary endpoint is a composite outcome measure which consists of (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death. Secondary endpoints are the individual components of the primary endpoint and functional outcome assessed by the modified Ranking scale.

Statistical analysis will be used to determine the odds of the primary and secondary endpoints in women who had subsequent pregnancies compared to those who did not.

Первичные конечные точки

  • Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death [Срок оценки: From date of first CeAD until date of latest follow-up assessed up to 35 years]
Вторичные конечные точки (5)
  • Number of participants with recurrent cervical artery dissection [Срок оценки: From date of first CeAD until date of latest follow-up assessed up to 35 years]
  • Number of participants with new ischemic stroke [Срок оценки: From date of first CeAD until date of latest follow-up assessed up to 35 years]
  • Number of participants with new hemorrhagic stroke [Срок оценки: From date of first CeAD until date of latest follow-up assessed up to 35 years]
  • Number of participants with death [Срок оценки: From date of first CeAD until date of latest follow-up assessed up to 35 years]
  • Functional outcome as assessed by modified Rankin Scale (mRS) [Срок оценки: At date of latest, individual follow-up assessed up to 35 years after first CeAD]

Критерии участия

Критерии включения

  • female
  • prior symptomatic cervical artery dissection (= index CeAD)
  • at least one long-term follow-up visit (at least 6 months after the initial event)
  • with information available on outcome events:
  • recurrent dissection
  • ischemic stroke
  • hemorrhagic stroke
  • functional outcome assessed by mRS score
  • with data on pregnancy after the initial event
  • at least 18 years old at the initial event

Критерии исключения

  • Male patients
  • Age <18 years
  • No long-term follow-up available or long-term follow-up < 6 months after initial event
  • No data on pregnancy after initial event available

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 2 центра
  • University of Utah — Salt Lake City
  • University of Virginia — Charlottesville
Германия · 2 центра
  • Charité Universitätsmedizin, Centrum für Schlaganfallforschung — Berlin
  • Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern — Munich
Швейцария · 2 центра
  • University Hospital Basel, Stroke Center — Basel
  • University Hospital Zurich, Stroke Center — Zurich
Аргентина · 1 центр
  • Stroke Unit Sanatorio Allende — Córdoba
Австрия · 1 центр
  • Department of Neurology, Medical University of Innsbruck — Innsbruck
Финляндия · 1 центр
  • Helsinki University Central Hospital — Helsinki
Израиль · 1 центр
  • Hadassah-Hebrew University Medical Center — Jerusalem
Италия · 1 центр
  • Neurology Clinic, University of Brescia — Brescia
Мексика · 1 центр
  • Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez — Mexico City

Идентификаторы

NCT: NCT06258109 · PB_2016_00547; ko23Engelter2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗