Health TrialsbyHealthPanel

Endothelial Dysfunction After SCI

ConditionsSpinal Cord InjuriesEndothelial Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCraig Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Chronic (>12 months) SCI

Motor complete (AIS A/B) SCI

Paraplegia (neurological level of injury [NLI] at T2 or below)

Disqualifiers

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)

Trial population

Potential participants of this study will all be willing and eligible adults who sustained a spinal cord injury, and adults who have never sustained a spinal cord injury. Participants of all races and ethnic backgrounds will be included in this study. A total up to 40 participants will be enrolled with the goal of 20 in each group to complete the protocol.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Intra-arterial Infusion of Vasoactive Agents

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Spinal Cord Injury3 interventions
Group B: Control (Non-Spinal Cord Injury)3 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 and isoproterenol at increasing concentrations.

Time frame
Measured at baseline and immediately after each vasoactive 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

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

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.

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

Denver Health and Hospital Authority

Collaborator

Source ClinicalTrials.gov
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