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Observational Study on Endothelial Function and Cardiovascular Risk in Spinal Cord Injury

This observational study is looking into why people with spinal cord injuries (SCI) have a higher risk of heart attacks and strokes earlier in life. We know that damage to the lining of blood vessels, called endothelial cells, can lead to these problems. This study will examine how well your blood vessels respond to certain drugs. We will infuse small amounts of acetylcholine, nitroprusside, and ascorbic acid into an artery in your arm and measure blood flow. This helps us understand how your endothelial cells are working and if oxidative stress (an imbalance in the body) plays a role. We are looking for 60 adults, aged 18-89, with a traumatic spinal cord injury (T2 or below, ASIA Impairment Scale A or B) that happened over 12 months ago. The study aims to measure how your blood vessels widen in response to these drugs and the levels of certain tiny particles from endothelial cells. The study's status is currently unclear.

Study design
This is an observational study with a planned enrollment of 60 participants. It is not a treatment study but aims to understand the mechanisms behind cardiovascular disease risk in people with spinal cord injuries.
What's involved
You would have a catheter placed in an artery in your non-dominant arm to infuse drugs. Blood flow in your forearm would be measured at different times during the infusions.
Compensation
Not stated in the trial record.
Follow-up
Measurements for endothelium-dependent and endothelium-independent vasodilation are taken at baseline and immediately after each drug dose for 3-5 minutes. Endothelial cell-derived microvesicle concentration is measured at baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06443151

Role of Endothelial Function in SCI CVD Risk

Recruiting
Not specifiedAges 18–89Observational
Craig Hospital
~60 participants
Updated 2024-08-20 on ClinicalTrials.gov
What's tested:Brachial intra-arterial infusion of vasoactive and antioxidant drugs (acetylcholine, nitroprusside, ascorbic acid)venous occlusion plethysmographyAcetylcholineSodium NitroprussideAscorbic acidvenous phlebotomy

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 (without acetylcholine) and immediately after each acetylcholine dose for 3-5 minutes.
+5 more outcomes measured

Conditions

Spinal Cord Injuries
Cardiovascular Diseases
Endothelial Dysfunction

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Andrew Park, MD · PRINCIPAL_INVESTIGATOR · Craig Hospital

Who to contact

Clare Morey, SLP-CCC
[email protected]
303-789-8621
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men and women of all races, ethnic backgrounds\>18 years of age
Traumatic spinal cord injury (Sports, Assault, Transport, Fall, Other Traumatic Causes)
Time since injury (\> 12 months)
Paraplegia Motor Complete Injury (neurological level of injury at T2 or below, ASIA Impairment Scale A or B

Exclusion

History of high blood pressure
History cardiovascular disease (coronary artery disease, congestive heart failure, myocardial infarction, cerebrovascular accident).
History high cholesterol
History of Diabetes Type I or Type II
History of Obstructive Pulmonary Disease
History of Chronic Kidney or Liver Disease
History of Cancer
History of Autoimmune Disease (Thyroid Disease, Lupus, Rheumatoid Arthritis, etc).
History of smoking tobacco in the last 12 months
History of alcohol use

What this trial measures

  • Endothelium-dependent vasodilationMeasured at baseline (without acetylcholine) and immediately after each acetylcholine 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 at increasing concentrations (8, 16, 32ug/ml).

  • 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.

  • Association of Endothelial cell-derived microvesicles to Endothelium-dependent vasodilationBaseline
  • 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.