NCT04510974

Brief Summary

The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2.4 years

First QC Date

August 10, 2020

Results QC Date

June 26, 2023

Last Update Submit

February 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pulse Wave Velocity (m/s)

    Determine average pulse wave velocity among the three groups.

    2 years

Secondary Outcomes (3)

  • Systolic Blood Pressure (mmHg)

    2 years

  • Plasma Renin (pg/ml)

    2 years

  • Norepinephrine (pg/ml)

    2 years

Study Arms (3)

Cervical SCI

Ages between 21-70 years old Injured between C1-T1 Wheelchair dependent AIS classification of A, B or C Injury occurred more than 1 year ago

Other: Spinal Cord Injury

Thoracic SCI

Ages between 21-70 Injured between T6-T12 Wheelchair dependent AIS classification of A, B or C Injury occurred more than 1 year ago

Other: Spinal Cord Injury

Able-bodied Control

Ages between 21-70

Interventions

Spinal Cord Injury

Cervical SCIThoracic SCI

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient individuals with SCI, flyers in town

You may qualify if:

  • SCI participants:
  • injured between C1-T1 and T6-T12
  • wheelchair dependent
  • AIS classification A, B or C
  • Injured occurred more than 1 year ago

You may not qualify if:

  • currently have an illness or infection
  • current smoker of at least 1 year
  • controlled or uncontrolled hypertension or diabetes mellitus
  • Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease)
  • cardiovascular disease (coronary heart disease, congestive heart failure, peripheral artery disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James J Peters VAMC

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Hypotension, OrthostaticSpinal Cord InjuriesHypotension

Interventions

Creb3l2 protein, rat

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Caitlyn Peters
Organization
James J Peters VA Medical Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 12, 2020

Study Start

June 30, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 20, 2025

Results First Posted

February 20, 2025

Record last verified: 2025-02

Locations