Endothelial Dysfunction After SCI

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Craig Hospital
Study ID
NCT07227727
Status
Recruiting
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Conditions

  • Endothelial Dysfunction
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Intra-arterial Infusion of Vasoactive Agents — PROCEDURE
    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-dependent vasodilation. ISO infusion is to evaluate β-adrenergic, NO-dependent endothelium-dependent vasodilation. SNP infusion is to assess endothelium-independent vasodilation.
  • Intra-arterial Vitamin C Infusion — PROCEDURE
    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.
  • Blood Sampling — PROCEDURE
    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)

Study Details

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.

Key Dates

Start date
Jul 31, 2025
Status verified
Nov 2025
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Spinal Cord Injury
    Willing and eligible adults over the age of 18 years who sustained a motor complete (AIS A/B) paraplegia (neurological level of injury at T2 or below) spinal cord injury greater than 12 months ago. Participants of all races and ethnic backgrounds will be included in this study.
  • Arm: Control (Non-Spinal Cord Injury)
    Adults greater than 18 years of age who have never sustained a spinal cord injury. Participants of all races and ethnic backgrounds will be included in this study

Primary Outcome Measure

Endothelium-dependent vasodilation [ Time Frame: Measured at baseline and immediately after each vasoactive dose for 3-5 minutes. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Craig HospitalEnglewoodColorado80113
Genevieve Madera, B.S.
[email protected]
7203454640
Andrew Park, MD
[email protected]
Andrew Park, MD (PRINCIPAL_INVESTIGATOR)
Christopher DeSouza, PhD (SUB_INVESTIGATOR)
Brian Stauffer, MD (SUB_INVESTIGATOR)

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By research site
Craig Hospital· Englewood, CO

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