RAAS and Arterial Stiffness in SCI

Completed

• Conditions: Arterial Stiffness; Renin Angiotensin Aldosterone System; Orthostatic Hypotension; Hypotension; Spinal Cord Injury

• Registration Number: NCT04510974
• Lead Sponsor: James J. Peters Veterans Affairs Medical Center

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.

Study Timeline

• Study Start: 2018-06-30
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Results First Submitted: 2023-06-26
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Results First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse Wave Velocity (m/s)	2 years	Determine average pulse wave velocity among the three groups.

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure (mmHg)	2 years	Determine differences in blood pressure among groups
Plasma Renin (pg/ml)	2 years	Determine differences in plasma renin among the groups
Norepinephrine (pg/ml)	2 years	Determine differences in plasma norepinephrine among the groups.

Trial Locations

Locations (1)

James J Peters VAMC; 🇺🇸 Bronx, New York, United States