Endothelial Dysfunction After SCI (EDASCI)

Craig Hospital

Status: Enrolling

Conditions: Endothelial Dysfunction; Spinal Cord Injuries

Treatments: Procedure: Blood Sampling; Procedure: Intra-arterial Vitamin C Infusion; Procedure: Intra-arterial Infusion of Vasoactive Agents

Study type: Observational

Funder types: Other

Identifiers

NCT07227727

1341523 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Vascular endothelial dysfunction is prevalent after spinal cord injury (SCI) which predispose individuals with SCI to accelerated, atherosclerotic cardiovascular disease (ASCVD) and future myocardial infarctions and ischemic strokes. The central objective of this study is to determine whether adults with SCI exhibit impaired endothelial function. Specifically, if endothelium-dependent vasodilation is impaired and if endothelial cell derived microvesicles (EMVs) are elevated and dysfunctional in adults with paraplegia. Endothelium-dependent vasodilation will be assessed by pharmacologically manipulating endothelial vasodilator function in live conscious humans with SCI and determining the role of circulating EMVs as both a systemic biomarker and mediator of endothelial dysfunction.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

40 participants in 2 patient groups

Spinal Cord Injury

Description:

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.

Treatment:

Procedure: Intra-arterial Infusion of Vasoactive Agents

Procedure: Intra-arterial Vitamin C Infusion

Procedure: Blood Sampling

Control (Non-Spinal Cord Injury)

Description:

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

Treatment:

Procedure: Intra-arterial Infusion of Vasoactive Agents

Procedure: Intra-arterial Vitamin C Infusion

Procedure: Blood Sampling