Vasoactive Agents for Endothelial Dysfunction After Spinal Cord Injury

(EDASCI Trial)

Overseen By Clare Morey, SLP-CCC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Hospital

Must not be taking: Statins, Beta-blockers, others

Disqualifiers: Chronic diseases, Smoking, Alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how blood vessels might malfunction after a spinal cord injury, potentially increasing the risk of heart problems. Researchers will test blood vessel expansion and blood flow improvement using special treatments, including an intra-arterial infusion of vasoactive agents and vitamin C. Participants needed include adults who have had a spinal cord injury affecting their legs for over a year and those without any spinal cord injury.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to improved treatments for complications related to spinal cord injuries.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any cardiovascular medications like statins or beta-blockers, as well as other medications that could affect the study's results.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that administering certain medications directly into the arteries has been studied for safety and effectiveness. Some studies indicate these medications can help manage blood pressure without causing major side effects. However, detailed safety information about their use specifically for spinal cord injuries remains limited.

Evidence suggests that vitamin C administered directly into the arteries is safe and can protect blood vessels from damage when blood flow is reduced, indicating it is generally well-tolerated for supporting blood vessel health.

Both treatments appear safe based on current research. However, specific information about their use in individuals with spinal cord injuries is scarce. Participants should consult their healthcare provider about the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for spinal cord injury, which often focus on managing symptoms and rehabilitation, the investigational treatments in this trial aim to directly target endothelial dysfunction, a key issue after such injuries. Researchers are excited about the intra-arterial infusion of vasoactive agents and Vitamin C because they have the potential to improve blood flow at a microvascular level, which could enhance recovery and function. This approach is unique because it uses targeted delivery directly to the affected area, potentially increasing efficacy and reducing systemic side effects.

What evidence suggests that these treatments could be effective for endothelial dysfunction after spinal cord injury?

Research has shown that delivering certain medications directly into the arteries can improve blood flow by widening blood vessels. This is crucial for people with spinal cord injuries, as their blood vessels might not function properly. In this trial, one group of participants will receive an intra-arterial infusion of vasoactive agents, which studies have shown to manage blood flow effectively. Another group will receive an intra-arterial infusion of vitamin C. Studies indicate that vitamin C, when administered directly into the arteries, can protect blood vessels from damage caused by poor blood flow. As an antioxidant, vitamin C helps protect and repair the lining of blood vessels. Both treatments show promise for supporting blood vessel health after spinal cord injuries. ^{1 2 3 5 6}

Who Is on the Research Team?

Andrew Park, MD

Principal Investigator

Craig Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a spinal cord injury.

I am over 18 years old.

I have had a spinal cord injury for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of endothelial function and microvesicle concentration are conducted

1 week

1 visit (in-person)

Pharmacological Manipulation

Endothelium-dependent and independent vasodilation are assessed through pharmacological manipulation

1 week

Multiple visits (in-person) for dose administration and measurement

Follow-up

Participants are monitored for safety and effectiveness after baseline and pharmacological assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intra-arterial Infusion of Vasoactive Agents
• Intra-arterial Vitamin C Infusion

How Is the Trial Designed?

Group I: Spinal Cord Injury Experimental Treatment 3 Interventions

Willing and eligible adults over the age of 18 years who sustained a motor complete (AIS A/B) paraplegia (neurological level of injury at T2 or below) spinal cord injury greater than 12 months ago. Participants of all races and ethnic backgrounds will be included in this study.

Group II: Control (Non-Spinal Cord Injury) Experimental Treatment 3 Interventions

Adults greater than 18 years of age who have never sustained a spinal cord injury. Participants of all races and ethnic backgrounds will be included in this study

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07227727?term=cardiology&locStr=United+States&country=United+States&aggFilters=status:

NCT07227727 | Endothelial Dysfunction After SCI This study plans to learn how endothelial cells, single cell lining of blood vessels may be dysfunctional after a spinal cord injury.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39137515/

Evaluation of Oral Vasoactive Medications to Maintain ... This study demonstrated shorter ICU length of stay and similar MAP goal success with PO agents as compared to vasopressors.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07227740?cond=cardiology&aggFilters=status%3Arec

Testosterone Deficiency and Endothelial Dysfunction After ... Endothelium-dependent vasodilation and t-PA capacity will be assessed via intra-arterial infusion of vasoactive drugs, with total forearm blood flow measured ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772529425000621

Current and emergent therapies targeting spinal cord injury The results from a recent clinical trial (NCT04697472) demonstrate the safety and efficacy of ARCEX therapy to improve hand and arm functions in people with ...

5. mdpi.com mdpi.com/2077-0383/14/3/902

Vasopressor Use in Acute Spinal Cord Injury This review explores updated guidelines and current evidence regarding MAP management and the use of vasopressors in SCI, focusing on their impact on spinal ...

6. tsaco.bmj.com tsaco.bmj.com/content/10/Suppl_1/e001788

Rethinking vasopressor use in the trauma bay: a shifting ... This narrative review aims to summarize the evidence behind trauma bay vasopressors and identify the potential role of vasoactive medications in the early ...