Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2025-07-31
2027-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
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-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
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
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)
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
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-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
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
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)
Interventions
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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-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
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
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)
Eligibility Criteria
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Inclusion Criteria
* Chronic (\>12 months) SCI
* Motor complete (AIS A/B) SCI
* Paraplegia (neurological level of injury \[NLI\] at T2 or below)
• Over age 18 years
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Craig Hospital
OTHER
University of Colorado, Boulder
OTHER
Denver Health and Hospital Authority
OTHER
Responsible Party
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Andrew Park
Physician Researcher at Craig Hospital
Principal Investigators
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Andrew Park, MD
Role: PRINCIPAL_INVESTIGATOR
Craig Hospital
Locations
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Craig Hospital
Englewood, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1341523
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1341523
Identifier Type: -
Identifier Source: org_study_id
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