Recruiting

Observational Study

Sponsor:

Craig Hospital

Code:

NCT07227727

Conditions

Spinal Cord Injuries

Endothelial Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Intra-arterial Infusion of Vasoactive Agents

Intra-arterial Vitamin C Infusion

Blood Sampling

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Endothelial Dysfunction

Study ID

NCT07227727

Start date

Jul 31, 2025

Status verified date

Nov, 2025

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

Interventions

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)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Genevieve Madera, BS

17203454640Gmadera@craighospital.org

Clare Morey, SLP-CCC

303.789. 8621Gquintero@craighospital.org

Locations

Craig Hospital

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Genevieve Madera, B.S.

7203454640Gmadera@craighospital.org

Andrew Park, MD

Apark@craighospital.org

Principal Investigator:

Andrew Park, MD

More Information

Sponsor

Craig Hospital

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • spinal cord injury
  • endothelium-dependent vasodilation
  • extracellular vesicles
  • microvesicles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Craig Hospital on 2025-11-14.