RAAS and Arterial Stiffness in SCI

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04510974
• Other study ID #: WEC-18-025
• Status: Active, not recruiting
• Start date: June 30, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2020
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Stiffness
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Renin Angiotensin Aldosterone System
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Spinal Cord Injury
Spinal Cord Injury

Locations

Country	Name	City	State
United States	James J Peters VAMC	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center	Kessler Foundation, Seton Hall University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave velocity (m/s)	Determine relationship between arterial stiffness, blood pressure, norepinephrine, and renin responses to head-up tilt among the groups.	2 years
Secondary	Systolic Blood Pressure (mmHg)	Determine differences in blood pressure among groups	2 years
Secondary	Plasma renin (pg/ml)	Determine differences in plasma renin among the groups	2 years
Secondary	Norepinephrine (pg/ml)	Determine differences in plasma norepinephrine among the groups.	2 years
Secondary	Norepinephrine and Renin	Describe the changes in norepinephrine and renin from supine rest to 60 degree tilt	2 years