Observational Study on Endothelial Dysfunction After Spinal Cord Injury

This study aims to understand why blood vessels may not work as well in people with spinal cord injuries (SCI). Researchers will measure how well your blood vessels can widen (vasodilate) and change blood flow. They will do this by infusing small amounts of drugs like acetylcholine (Ach), isoproterenol (ISO), and sodium nitroprusside (SNP) into your arm. They will also infuse Vitamin C to see if it helps. Blood samples will be taken to look for markers of blood vessel health. This study is for adults over 18 with chronic SCI (paraplegia) or healthy adults without SCI. The goal is to learn more about how to reduce the risk of heart attacks and strokes in people with SCI. The current status of this study is unclear.

Study design
This is an observational study involving 40 participants. It compares adults with spinal cord injuries to adults without injuries.
What's involved
You would have a catheter placed in your arm for infusions of vasoactive agents and Vitamin C. Forearm blood flow will be measured, and about 50 mL of blood will be drawn.
Compensation
Not stated in the trial record.
Follow-up
Blood vessel function will be measured at baseline and immediately after each drug dose for 3-5 minutes. Endothelial cell-derived microvesicle concentration will be measured at baseline.

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NCT07227727

Endothelial Dysfunction After SCI

Recruiting
Not specifiedAges 18+Observational
Craig Hospital
~40 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:Intra-arterial Infusion of Vasoactive AgentsIntra-arterial Vitamin C InfusionBlood Sampling

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Endothelium-dependent vasodilation
Measured over Measured at baseline and immediately after each vasoactive dose for 3-5 minutes.
+4 more outcomes measured
Spinal Cord Injuries
Endothelial Dysfunction
1 sites across 1 states
Colorado1
  • Andrew Park, MD · PRINCIPAL_INVESTIGATOR · Craig Hospital

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Endothelium-dependent vasodilationMeasured at baseline and immediately after each vasoactive dose for 3-5 minutes.

    Total forearm blood flow with be measured by strain gauge venous plethysmography under baseline conditions and under pharmacological manipulation with acetylcholine and isoproterenol at increasing concentrations.

  • Endothelium-independent vasodilationMeasured at baseline (without sodium nitroprusside) and immediately after each sodium nitroprusside dose for 3-5 minutes.

    Total forearm blood flow with be measured by strain gauge venous plethysmography under baseline conditions and under pharmacological manipulation with sodium nitroprusside at increasing concentrations (1, 2, 4ug/ml).

  • Endothelial cell-derived microvesicles concentrationBaseline

    Endothelial cell-derived microvesicles will be collected from venous blood samples and counted used flow cytometry to determine a circulating concentration.

  • Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells nitric oxide bioavailabilityBaseline

    Endothelial cell-derived microvesicles will be sorted and collected by fluorescence-activated cell sorting (FACS) flow cytometry. The endothelial cell-derived microvesicles will be co-cultured with human coronary artery endothelial cells. Endothelial Nitric Oxide Synthase and phosphorylation sites of interest will be measured by intracellular protein expression quantification of whole cell lysates by capillary electrophoresis immunoassays. Nitric oxide production will be assessed by total nitric oxide and nitrate/nitrite parameter assays.

  • Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells reactive oxygen species and antioxidant capacityBaseline

    Endothelial cell-derived microvesicles will be sorted and collected by fluorescence-activated cell sorting (FACS) flow cytometry. The endothelial cell-derived microvesicles will be co-cultured with human coronary artery endothelial cells. Super oxide dismutase and catalase expression will be measured by intracellular protein expression quantification of whole cell lysates by capillary electrophoresis immunoassays. Intracellular oxidative stress will be assessed by ROS-Glo H2O2 assay.