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Completed

NCT Number: NCT04510974

RAAS and Arterial Stiffness in SCI

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.

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Key information

Conditions

Arterial Stiffness Autonomic Nervous System Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Hypotension Orthostatic Intolerance Primary Dysautonomias Renin Angiotensin Aldosterone System Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

James J Peters VAMC

The Bronx, New York, 10468, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spinal Cord Injury

Other

Spinal Cord Injury

Primary outcomes

  1. Pulse Wave Velocity (m/s)

    Time frame: 2 years

    Determine average pulse wave velocity among the three groups.

Secondary outcomes

  1. Systolic Blood Pressure (mmHg)

    Time frame: 2 years

    Determine differences in blood pressure among groups

  2. Plasma Renin (pg/ml)

    Time frame: 2 years

    Determine differences in plasma renin among the groups

  3. Norepinephrine (pg/ml)

    Time frame: 2 years

    Determine differences in plasma norepinephrine among the groups.

Sponsors and collaborators

Lead sponsor

James J. Peters Veterans Affairs Medical Center

Fed

Collaborators

  • Kessler Foundation
  • Seton Hall University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2020
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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