RAAS and Arterial Stiffness in SCI

NCT ID: NCT04510974

Last Updated: 2025-02-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-30

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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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. Arterial stiffness and blood pressure will be collected in the laying down position. A blood sample of norepinephrine and plasma renin will also be collected. The participant will tilt to 30, 45 and 60 degrees for 10 minutes at each angel. Blood pressure and heart rate will be monitored at each angle. Another blood sample of renin and norepinephrine will be collected at the end of 10 minutes at 60 degrees.

Conditions

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Arterial Stiffness Renin Angiotensin Aldosterone System Orthostatic Hypotension Spinal Cord Injury Hypotension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Spinal Cord Injury

Intervention Type 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

Spinal Cord Injury

Intervention Type OTHER

Spinal Cord Injury

Able-bodied Control

Ages between 21-70

No interventions assigned to this group

Interventions

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Spinal Cord Injury

Spinal Cord Injury

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role collaborator

Seton Hall University

OTHER

Sponsor Role collaborator

James J. Peters Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Jill M. Wecht, Ed.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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James J Peters VAMC

The Bronx, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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WEC-18-025

Identifier Type: -

Identifier Source: org_study_id

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