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Recruiting NCT07227727

Endothelial Dysfunction After SCI

— Observational Spinal Cord Injuries Endothelial Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intra-arterial Infusion of Vasoactive Agents, Intra-arterial Vitamin C Infusion, Blood Sampling.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Endothelial Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure 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
  • Procedure 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.
  • Procedure 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)

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Craig Hospital — Englewood

Identifiers

NCT: NCT07227727 · 1341523 · 1341523

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗