RAAS and Arterial Stiffness in SCI

August 10, 2020 updated by: Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10468
        • James J Peters VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatient individuals with SCI, flyers in town

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Spinal Cord Injury
Able-bodied Control
Ages between 21-70

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse wave velocity (m/s)
Time Frame: 2 years
Determine relationship between arterial stiffness, blood pressure, norepinephrine, and renin responses to head-up tilt among the groups.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure (mmHg)
Time Frame: 2 years
Determine differences in blood pressure among groups
2 years
Plasma renin (pg/ml)
Time Frame: 2 years
Determine differences in plasma renin among the groups
2 years
Norepinephrine (pg/ml)
Time Frame: 2 years
Determine differences in plasma norepinephrine among the groups.
2 years
Norepinephrine and Renin
Time Frame: 2 years
Describe the changes in norepinephrine and renin from supine rest to 60 degree tilt
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James J. Peters Veterans Affairs Medical Center

Collaborators

Kessler Foundation
Seton Hall University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEC-18-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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