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Идёт набор NCT05756257

Blood Pressure Variability and Ischemic Stroke Outcome

Наблюдательное Acute Ischemic Stroke Blood Pressure Variability

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: Acute Ischemic Stroke, Blood Pressure Variability. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this observational study is to evaluate the role of blood pressure (BPV) variability in patients suffering from acute ischemic stroke. The main questions it aims to answer are: 1. To determine the association of BPV with functional/cognitive outcome after ischemic stroke. 2. To determine a pathophysiologic mechanism of BPV's deleterious effect on functional outcome. 3. To evaluate potential treatment targets to pharmacologically reduce BPV after ischemic stroke.

Подробное описание

Increased blood pressure variability (BPV) has consistently been associated with two to three times higher risk of disability or mortality after acute ischemic stroke (AIS) in retrospective analyses, independent of mean blood pressure. The investigators' central hypothesis is that increased BPV is harmful after AIS and warrants reduction. However, prior BPV research in AIS patients has been retrospective and limited by non-standardized BP measurement and, therefore, BPV is not mentioned in current stroke guidelines. To address the limitations of prior BPV research, determine mechanisms of BPV's deleterious effect, and identify potentially effective methods to reduce BPV, the proposed study will: 1) prospectively validate that "short-term" and "long-term" BPV after AIS onset is associated with functional outcome and define the effect size of different levels of BPV, 2) utilize portable MRI to confirm that final infarct volume is mechanistically related to BPV, and 3) utilize bedside pupillometry to determine how the autonomic nervous system contributes to BPV after AIS and evaluate the class effect of antihypertensive medications on BPV. To achieve these goals, the study will enroll 150 patients who have anterior circulation stroke and a baseline NIH Stroke Scale ≥4 within 48 hours of AIS onset at three study sites. With completion of the Aims, the study will define the outcome for a future trial, the effect size of BPV on individual outcomes and composites, the duration for lowering BPV (24-72 hours vs. weeks or months), and potential interventions to reduce BPV. Pharmacologic BPV reduction would be an inexpensive and widely available intervention, able to be administered in a range of healthcare settings. By completing the proposed aims, the investigators will be ideally positioned to test accessible targeted interventions to diminish the morbidity and mortality of AIS.

Первичные конечные точки

  • Change in Functional outcome [Срок оценки: 90 days and 1 Year]
  • Imaging outcome [Срок оценки: 72 hours +/- 60 hours]
Вторичные конечные точки (9)
  • Incidence of stroke [Срок оценки: 90 days]
  • Incidence of stroke [Срок оценки: 1 year]
  • Change in Montreal Cognitive Assessment scale (MoCA-BLIND) to assess post-stroke cognition [Срок оценки: 3 days and 1 year]
  • Change in Oral Trails A and B Test to assess post-stroke cognition [Срок оценки: 3 days and 1 year]
  • Change in Category Fluency tests to assess post-stroke cognition [Срок оценки: 3 days and 1 year]
  • Change in Patient Health Questionnaire (PHQ-9) to assess mood [Срок оценки: 3 days and 1 year]
  • Change in General Anxiety Disorder-7 (GAD-7) to assess mood [Срок оценки: 3 days and 1 year]
  • Change in Lawton Instrumental Activities of Daily Living (IADL) Scale to assess adaptive functioning [Срок оценки: 3 days and 1 year]
  • Change in Katz Index of Independence in Activities of Daily Living (ADL) to assess adaptive functioning [Срок оценки: 3 days and 1 year]

Критерии участия

Критерии включения

  • Ischemic stroke according to the American Heart Association (AHA) definition and either:
  • CT or MRI showing ischemic stroke in the anterior circulation (frontal, parietal or superior temporal lobes), or
  • Occlusion of the internal carotid, middle cerebral or anterior cerebral arteries on computed tomography angiography (CTA) or magnetic resonance angiography (MRA)

Onset of ischemic stroke within 48 hours and able to get baseline pMRI within 72 hours of arrival

4\) NIH Stroke Scale ≥ 4 at time of enrollment

Критерии исключения

  • Pre-morbid mRS ≥3
  • Predicted hospital system admission <72 hours
  • Pacemaker or other MRI contraindications per American College of Radiology guidelines

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • Yale-New Haven Hospital — New Haven
  • University of Chicago Medical Center — Chicago
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT05756257 · Pro00065750 · 2000034922 · 1R01NS130189-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗