Health TrialsbyHealthPanel

Role of Endothelial Function in SCI CVD Risk

ConditionsSpinal Cord InjuriesCardiovascular DiseasesEndothelial Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorCraig Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Men and women of all races, ethnic backgrounds, over the age of 18 years with history chronic motor complete paraplegia, but free of overt chronic diseases assessed by clinically documented medical history, physical examination, and blood chemistries and hematological evaluation.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Brachial intra-arterial infusion of vasoactive and antioxidant drugs (acetylcholine, nitroprusside, ascorbic acid)

    Procedure/Surgery

    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/Surgery

    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/Surgery

    Venous blood samples will be collected to measure baseline cardiometabolic characteristics and isolate endothelial cell microvesicles for characterizations and in vitro experiments.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Spinal Cord Injury6 interventions
Group B: Control (Non-Spinal Cord Injury)6 interventions

Trial outcomes

Primary outcomes

1

Endothelium-dependent vasodilation

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).

Time frame
Measured at baseline (without acetylcholine) and immediately after each acetylcholine dose for 3-5 minutes.
2

Endothelium-independent vasodilation

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).

Time frame
Measured at baseline (without sodium nitroprusside) and immediately after each sodium nitroprusside dose for 3-5 minutes.
3

Endothelial cell-derived microvesicles concentration

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

Time frame
Baseline
4

Association of Endothelial cell-derived microvesicles to Endothelium-dependent vasodilation

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Craig Hospital

Lead sponsor

University of Colorado, Boulder

Collaborator

Source ClinicalTrials.gov
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