RAAS and Arterial Stiffness in SCI

• Sponsor: James J. Peters Veterans Affairs Medical Center (U.S. Fed)
• Overall Status: Unknown status
• CT.gov ID: NCT04510974
• Collaborator: Kessler Foundation (Other), Seton Hall University (Other)
• Enrollment: 33
• Location: 1
• Anticipated Duration (Months): 29.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Stiffness; Renin Angiotensin Aldosterone System; Orthostatic Hypotension; Spinal Cord Injury; Hypotension	Other: Spinal Cord Injury

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 Design

• Study Type: Observational
• Actual Enrollment: 33 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Orthostatic Blood Pressure and Arterial Stiffness in Persons With SCI: The Effect of RAAS System
• Actual Study Start Date: Jun 30, 2018
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Pulse wave velocity (m/s) [2 years]

   Determine relationship between arterial stiffness, blood pressure, norepinephrine, and renin responses to head-up tilt among the groups.

Secondary Outcome Measures

1. Systolic Blood Pressure (mmHg) [2 years]

   Determine differences in blood pressure among groups

2. Plasma renin (pg/ml) [2 years]

   Determine differences in plasma renin among the groups

3. Norepinephrine (pg/ml) [2 years]

   Determine differences in plasma norepinephrine among the groups.

4. Norepinephrine and Renin [2 years]

   Describe the changes in norepinephrine and renin from supine rest to 60 degree tilt

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James J Peters VAMC	Bronx	New York	United States	10468

Sponsors and Collaborators

• James J. Peters Veterans Affairs Medical Center
• Kessler Foundation
• Seton Hall University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jill M. Wecht, Ed.D., Health Science Scientist, James J. Peters Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT04510974
• Other Study ID Numbers: WEC-18-025
• First Posted: Aug 12, 2020
• Last Update Posted: Aug 12, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Cord Injuries; Hypotension, Orthostatic; Hypotension

Study Results

No Results Posted as of Aug 12, 2020