Role of Endothelial Function in SCI CVD Risk

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Craig Hospital
Study ID
NCT06443151
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Endothelial Dysfunction
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Brachial intra-arterial infusion of vasoactive and antioxidant drugs (acetylcholine, nitroprusside, ascorbic acid) — PROCEDURE
    The brachial artery in the non-dominant arm will be catheterized to infuse endothelium-dependent vasodilator acetylcholine, endothelium-independent vasodilator nitroprusside, and antioxidant ascorbic acid at concentrations to have isolated effect in the forearm.
  • venous occlusion plethysmography — PROCEDURE
    Whole forearm blood flow will be measured by mercury-strain gauge while venous occlusion is applied to the forearm and hand by rapid-cuff inflation to sub-arterial pressures. Changes in whole forearm blood flow with be measured at baseline, endothelial agonists, and removal of oxidative stress via acorbic acid.
  • Acetylcholine — DRUG
    Endothelium-dependent vasodilation will then be assessed by changes in FBF in response to intra-arterial infusions of the endothelial agonist acetylcholine infused at rates of 4.0, 8.0, 16.0 μg/100 mL of forearm tissue/min to generate a dose-response curve.
  • Sodium Nitroprusside — DRUG
    Endothelium-independent vasodilation will be assessed by changes in forearm blood flow in response to intra-arterial infusions of sodium nitroprusside at 1.0, 2.0, 4.0 μg/100 mL forearm tissue/min.
  • Ascorbic acid — DRUG
    Ascorbic acid will be infused at a constant rate (12 mg/100 mL tissue/min) and maintained at the same rate while the acetylcholine and sodium nitroprusside dose-response curves are repeated.
  • venous phlebotomy — PROCEDURE
    Venous blood samples will be collected to measure baseline cardiometabolic characteristics and isolate endothelial cell microvesicles for characterizations and in vitro experiments.

Study Details

Individuals with spinal cord injury have heart attacks and strokes more frequently, and much earlier in life. People with spinal cord injuries develop plaque in vessels much faster, and the reasons why are unclear. Doctors generally attributed the increased risk with weight gain and developing diabetes, but many studies have shown that even without these common factors, plaque in vessels is developing more often and faster. Endothelial cells are a single layer of cells that line all vessels in the body and plays an important role in vessel health. Damage to endothelial cells is known to lead to heart attacks and strokes. Past studies on endothelial cells of people with spinal cord injury have been unclear. The investigators have new data that these cells are unhealthy after spinal cord injury a measurement. This includes measuring endothelial health by directly altering its function using a catheter in the arm and measuring small particles in blood called endothelial microvesicles. If the project is successful, the investigators will learn important information on the health of endothelial cells after spinal cord injury. The investigators will also be able to use these markers of endothelial cell function to create treatments to improve vessel health and prevent heart attacks and strokes later in life in people with spinal cord injury.

Key Dates

Start date
Sep 1, 2024
Status verified
Aug 2024
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Spinal Cord Injury
    Men and women of all races, ethnic backgrounds, over the age of 18 years: adults with chronic (\>12 months), motor complete (AIS A/B) SCI with paraplegia (neurological level of injury \[NLI\] at T2 or below).
  • Arm: Control (Non-Spinal Cord Injury)
    Non-injured men and women of all races, ethnic backgrounds, over the age of 18 years.

Primary Outcome Measure

Endothelium-dependent vasodilation [ Time Frame: Measured at baseline (without acetylcholine) and immediately after each acetylcholine dose for 3-5 minutes. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Craig HospitalEnglewoodColorado80113
Clare Morey, SLP-CCC
[email protected]
303-789-8621
Genevieve Quintero, B.S.
[email protected]
Andrew Park, MD (PRINCIPAL_INVESTIGATOR)
Christopher DeSouza, PhD (PRINCIPAL_INVESTIGATOR)
Brian Stauffer, MD (PRINCIPAL_INVESTIGATOR)

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Craig Hospital· Englewood, CO

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