Blood vessel (endothelial) dysfunction after spinal cord injury
Endothelial Dysfunction After SCI: Mechanism and Therapeutic Target for SCI-related Cardiovascular Disease
This research will test whether blood vessels in adults with chronic paraplegia do not widen properly and whether circulating endothelial microvesicles help explain those changes by comparing them to adults without an injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Craig Hospital Academic / other |
| Locations | 1 site (Englewood, Colorado) |
| Trial ID | NCT07227727 on ClinicalTrials.gov |
What this trial studies
This observational study compares adults with chronic, motor-complete paraplegia to non-injured adults to determine if endothelium-dependent vasodilation is impaired after spinal cord injury. Investigators will give intra-arterial vasoactive agents and vitamin C in awake participants and measure vessel responses directly, alongside blood sampling for endothelial-derived microvesicles (EMVs). The study will test whether EMVs are elevated and dysfunctional and whether they correlate with or mediate impaired vasodilation. Participants with overt chronic disease, recent surgery, active infection, tobacco use, substance misuse, or on cardiovascular medications are excluded to limit confounding factors.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic (>12 months), motor-complete paraplegia (AIS A/B) at T2 or below who do not have major chronic illnesses and are not taking cardiovascular medications.
Not a fit: People with active infection, recent surgery, current smoking, significant alcohol or drug misuse, overt chronic diseases, or those taking cardiovascular drugs are unlikely to be included or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could identify blood markers and mechanisms that help reduce heart attack and stroke risk in people with spinal cord injury.
How similar studies have performed: Prior research has documented endothelial dysfunction and elevated EMVs after spinal cord injury, but few studies have combined intra-arterial pharmacologic testing with EMV measurements, so this protocol is partly supported by earlier findings and partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
SCI Inclusion Criteria * Over age 18 years * Chronic (\>12 months) SCI * Motor complete (AIS A/B) SCI * Paraplegia (neurological level of injury \[NLI\] at T2 or below) Non-injured Inclusion Criteria • Over age 18 years Exclusion Criteria (Both SCI and Non-injured) * 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) * Report more than low-risk alcohol consumption * History of drug abuse * Currently taking cardiovascular (statins, beta-blockers) therapeutics and/or other medications that could influence the outcome measures
Where this trial is running
Englewood, Colorado
- Craig Hospital — Englewood, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Park, MD — Craig Hospital
- Study coordinator: Genevieve Madera, BS
- Email: Gmadera@craighospital.org
- Phone: 17203454640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.