NCT07227740 Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury
| NCT ID | NCT07227740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Craig Hospital |
| Condition | Spinal Cord Injuries |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2028-07-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2025-07-15 with a primary completion date of 2028-07-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Heart attacks and strokes are among the most common causes of premature death in individuals living with spinal cord injury (SCI) and appear to occur earlier in life. The factors that lead to the heighten and accelerated risk of heart attacks and strokes in adults living with SCI remain poorly understood. The investigators aim to uncover why this happens and find ways to prevent it. Our research focuses on how important cells which line blood vessels, called endothelial cells, function after SCI. The investigators test endothelial function in live conscious people with SCI. The investigators also study signaling molecules endothelial cells release called endothelial cell derived microvesicles (EMVs), which the investigators can measure in blood to tell us the health of endothelial cells. By using these rigorous tests of vascular function, the investigators have determined that endothelial cells appear dysfunctional after SCI. The investigators also know that many men with SCI have low testosterone levels. Our team has studied testosterone's effects on endothelial dysfunction and believe low testosterone may be contributing to endothelial dysfunction after SCI. By understanding these mechanisms, the investigators hope to improve the lives of those living with SCI and reduce their risk for heart attacks and strokes. The investigators propose to study the influence of testosterone on endothelial function by using state-of-the-art clinical and laboratory experiments to assess endothelial function in men with SCI with low and normal testosterone levels.
Eligibility Criteria
Inclusion Criteria: * Between ages 18-89 years of age * Male Sex * History of motor complete (AIS A/B) paraplegia (NLI T3 or Below) * Time since injury \<6 months at time of enrollment (Subacute injury) * Testosterone Deficiency defined as \< 300ng/dL Exclusion Criteria: * Overt cardiovascular disease assessed by a) medical history, b) physical examination c) electrocardiogram * Anaphylaxis to betadine, lidocaine, iodine * Active infection at time of enrollment. * Recent surgery (\<1 month) at time of enrollment. * History smoking tobacco (currently or in the past 12 months) * History of more than low-risk history of alcohol consumption * History of drug abuse * History of use of cardiovascular-acting (i.e. statins, beta-blockers) therapeutics * History of other health habits, medications, and supplements that could influence the outcome measures deemed by principal investigators and investigative team.
Contact & Investigator
Andrew Park, MD
PRINCIPAL INVESTIGATOR
Craig Hospital
Frequently Asked Questions
Who can join the NCT07227740 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 89 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07227740 currently recruiting?
Yes, NCT07227740 is actively recruiting participants. Contact the research team at Gmadera@craighospital.org for enrollment information.
Where is the NCT07227740 trial being conducted?
This trial is being conducted at Englewood, United States.
Who is sponsoring the NCT07227740 clinical trial?
NCT07227740 is sponsored by Craig Hospital. The principal investigator is Andrew Park, MD at Craig Hospital. The trial plans to enroll 48 participants.