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Clinical Trials/NCT04510974
NCT04510974
Completed
Not Applicable

Orthostatic Blood Pressure and Arterial Stiffness in Persons With SCI: The Effect of RAAS System

James J. Peters Veterans Affairs Medical Center1 site in 1 country33 target enrollmentJune 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arterial Stiffness
Sponsor
James J. Peters Veterans Affairs Medical Center
Enrollment
33
Locations
1
Primary Endpoint
Pulse Wave Velocity (m/s)
Status
Completed
Last Updated
last year

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2018
End Date
December 1, 2020
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
James J. Peters Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Jill M. Wecht, Ed.D.

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Pulse Wave Velocity (m/s)

Time Frame: 2 years

Determine average pulse wave velocity among the three groups.

Secondary Outcomes

  • Systolic Blood Pressure (mmHg)(2 years)
  • Plasma Renin (pg/ml)(2 years)
  • Norepinephrine (pg/ml)(2 years)

Study Sites (1)

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