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Control (Non-Spinal Cord Injury) for Spinal Cord Injury

N/A
Recruiting
Led By Andrew Park, MD
Research Sponsored by Craig Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

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.

Eligible Conditions
  • Spinal Cord Injury
  • Cardiovascular Disease
  • Endothelial Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Endothelial cell-derived microvesicles concentration
Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells nitric oxide bioavailability
Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells reactive oxygen species and antioxidant capacity
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Spinal Cord InjuryExperimental Treatment6 Interventions
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).
Group II: Control (Non-Spinal Cord Injury)Experimental Treatment6 Interventions
Non-injured men and women of all races, ethnic backgrounds, over the age of 18 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ascorbic acid
2018
Completed Phase 4
~650
Acetylcholine
2013
Completed Phase 2
~220
Sodium Nitroprusside
2018
Completed Phase 1
~240

Find a Location

Who is running the clinical trial?

Craig HospitalLead Sponsor
41 Previous Clinical Trials
8,359 Total Patients Enrolled
University of Colorado, BoulderOTHER
122 Previous Clinical Trials
29,300 Total Patients Enrolled
Andrew Park, MDPrincipal InvestigatorCraig Hospital
~40 spots leftby Mar 2027