Endothelial Dysfunction After SCI

NCT ID: NCT07227727

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2027-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injuries Endothelial Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Spinal Cord Injury

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.

Intra-arterial Infusion of Vasoactive Agents

Intervention Type PROCEDURE

A catheter is placed in the brachial artery of the non-dominant arm, and small doses of vasoactive drugs \[acetylcholine (Ach), isoproterenol (ISO), sodium nitroprusside (SNP)\] are infused. Forearm blood flow (FBF) is measured using venous occlusion plethysmography. The purpose of this procedure is to assess endothelium-dependent and independent vasodilation by stimulating different vascular pathways. The Ach infusion is to test muscarinic receptor, nitro oxide (NO) dependent, endothelium-dependent vasodilation. ISO infusion is to evaluate β-adrenergic, NO-dependent endothelium-dependent vasodilation. SNP infusion is to assess endothelium-independent vasodilation.

Intra-arterial Vitamin C Infusion

Intervention Type PROCEDURE

Vitamin C, a potent antioxidant, will be infused into the arm and forearm blood flow (FBF) will be re-evaluated to determine whether oxidative stress contributes to endothelial dysfunction.

Blood Sampling

Intervention Type PROCEDURE

Blood will be sampled from the antecubital vein (\~50 mL) for biomarker analysis. This is to assess circulating biochemical and molecular indicators of vascular health and inflammation including levels of endothelial cell derived microvesicles (EMVs)

Control (Non-Spinal Cord Injury)

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

Intra-arterial Infusion of Vasoactive Agents

Intervention Type PROCEDURE

A catheter is placed in the brachial artery of the non-dominant arm, and small doses of vasoactive drugs \[acetylcholine (Ach), isoproterenol (ISO), sodium nitroprusside (SNP)\] are infused. Forearm blood flow (FBF) is measured using venous occlusion plethysmography. The purpose of this procedure is to assess endothelium-dependent and independent vasodilation by stimulating different vascular pathways. The Ach infusion is to test muscarinic receptor, nitro oxide (NO) dependent, endothelium-dependent vasodilation. ISO infusion is to evaluate β-adrenergic, NO-dependent endothelium-dependent vasodilation. SNP infusion is to assess endothelium-independent vasodilation.

Intra-arterial Vitamin C Infusion

Intervention Type PROCEDURE

Vitamin C, a potent antioxidant, will be infused into the arm and forearm blood flow (FBF) will be re-evaluated to determine whether oxidative stress contributes to endothelial dysfunction.

Blood Sampling

Intervention Type PROCEDURE

Blood will be sampled from the antecubital vein (\~50 mL) for biomarker analysis. This is to assess circulating biochemical and molecular indicators of vascular health and inflammation including levels of endothelial cell derived microvesicles (EMVs)

Interventions

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Intra-arterial Infusion of Vasoactive Agents

A catheter is placed in the brachial artery of the non-dominant arm, and small doses of vasoactive drugs \[acetylcholine (Ach), isoproterenol (ISO), sodium nitroprusside (SNP)\] are infused. Forearm blood flow (FBF) is measured using venous occlusion plethysmography. The purpose of this procedure is to assess endothelium-dependent and independent vasodilation by stimulating different vascular pathways. The Ach infusion is to test muscarinic receptor, nitro oxide (NO) dependent, endothelium-dependent vasodilation. ISO infusion is to evaluate β-adrenergic, NO-dependent endothelium-dependent vasodilation. SNP infusion is to assess endothelium-independent vasodilation.

Intervention Type PROCEDURE

Intra-arterial Vitamin C Infusion

Vitamin C, a potent antioxidant, will be infused into the arm and forearm blood flow (FBF) will be re-evaluated to determine whether oxidative stress contributes to endothelial dysfunction.

Intervention Type PROCEDURE

Blood Sampling

Blood will be sampled from the antecubital vein (\~50 mL) for biomarker analysis. This is to assess circulating biochemical and molecular indicators of vascular health and inflammation including levels of endothelial cell derived microvesicles (EMVs)

Intervention Type PROCEDURE

Eligibility Criteria

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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)


• Over age 18 years

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Craig Hospital

OTHER

Sponsor Role lead

University of Colorado, Boulder

OTHER

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role collaborator

Responsible Party

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Andrew Park

Physician Researcher at Craig Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Park, MD

Role: PRINCIPAL_INVESTIGATOR

Craig Hospital

Locations

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Craig Hospital

Englewood, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Genevieve Madera, BS

Role: CONTACT

17203454640

Clare Morey, SLP-CCC

Role: CONTACT

303.789. 8621

Facility Contacts

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Genevieve Madera, B.S.

Role: primary

7203454640

Andrew Park, MD

Role: backup

Other Identifiers

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1341523

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1341523

Identifier Type: -

Identifier Source: org_study_id

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