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Идёт набор NCT07227727

Endothelial Dysfunction After SCI

— Наблюдательное Spinal Cord Injuries Endothelial Dysfunction

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: Intra-arterial Infusion of Vasoactive Agents, Intra-arterial Vitamin C Infusion, Blood Sampling.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries, Endothelial Dysfunction. 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
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Официальное название

Endothelial Dysfunction After SCI: Mechanism and Therapeutic Target for SCI-related Cardiovascular Disease

Обзор

This study plans to learn how endothelial cells, single cell lining of blood vessels may be dysfunctional after a spinal cord injury. Endothelial dysfunction will be measured by the capacity of blood vessels to vasodilate (increase in size) and alter blood flow is lower in adults with a spinal cord injury in comparison to adults without a spinal cord injury. The mechanisms which may alter this function may be critical in reducing the risk of heart attacks and strokes in people with spinal cord injuries.

Подробное описание

Vascular endothelial dysfunction is prevalent after spinal cord injury (SCI) which predispose individuals with SCI to accelerated, atherosclerotic cardiovascular disease (ASCVD) and future myocardial infarctions and ischemic strokes. The central objective of this study is to determine whether adults with SCI exhibit impaired endothelial function. Specifically, if endothelium-dependent vasodilation is impaired and if endothelial cell derived microvesicles (EMVs) are elevated and dysfunctional in adults with paraplegia. Endothelium-dependent vasodilation will be assessed by pharmacologically manipulating endothelial vasodilator function in live conscious humans with SCI and determining the role of circulating EMVs as both a systemic biomarker and mediator of endothelial dysfunction.

Вмешательства

  • Процедура Intra-arterial Infusion of Vasoactive Agents
    A catheter is placed in the brachial artery of the non-dominant arm, and small doses of vasoactive drugs \[acetylcholine (Ach), isoproterenol (ISO), sodium nitroprusside (SNP)\] are infused. Forearm blood flow (FBF) is measured using venous occlusion plethysmography. The purpose of this procedure is to assess endothelium-dependent and independent vasodilation by stimulating different vascular pathways. The Ach infusion is to test muscarinic receptor, nitro oxide (NO) dependent, endothelium-depen
  • Процедура Intra-arterial Vitamin C Infusion
    Vitamin C, a potent antioxidant, will be infused into the arm and forearm blood flow (FBF) will be re-evaluated to determine whether oxidative stress contributes to endothelial dysfunction.
  • Процедура Blood Sampling
    Blood will be sampled from the antecubital vein (\~50 mL) for biomarker analysis. This is to assess circulating biochemical and molecular indicators of vascular health and inflammation including levels of endothelial cell derived microvesicles (EMVs)

Первичные конечные точки

  • Endothelium-dependent vasodilation [Срок оценки: Measured at baseline and immediately after each vasoactive dose for 3-5 minutes.]
  • Endothelium-independent vasodilation [Срок оценки: Measured at baseline (without sodium nitroprusside) and immediately after each sodium nitroprusside dose for 3-5 minutes.]
  • Endothelial cell-derived microvesicles concentration [Срок оценки: Baseline]
  • Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells nitric oxide bioavailability [Срок оценки: Baseline]
  • Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells reactive oxygen species and antioxidant capacity [Срок оценки: Baseline]

Критерии участия

SCI Inclusion Criteria

  • Over age 18 years
  • Chronic (>12 months) SCI
  • Motor complete (AIS A/B) SCI
  • Paraplegia (neurological level of injury \[NLI\] at T2 or below)

Non-injured Inclusion Criteria

  • Over age 18 years

Exclusion Criteria (Both SCI and Non-injured)

  • Overt chronic diseases as assessed by: a) clinically documented medical history; b) physical examination; c) blood pressure and ECG at rest; and d) complete blood chemistries and hematological evaluation.
  • Active infection
  • Recent (< 3 months) surgery
  • Current smoking history (within past 12 months)
  • Report more than low-risk alcohol consumption
  • History of drug abuse
  • Currently taking cardiovascular (statins, beta-blockers) therapeutics and/or other medications that could influence the outcome measures

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Craig Hospital — Englewood

Идентификаторы

NCT: NCT07227727 · 1341523 · 1341523

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗