Arterial Stiffness, Hypotension, Orthostatic Hypotension, Renin Angiotensin Aldosterone System, Spinal Cord Injury
Conditions
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.
Interventions
OTHERSpinal Cord Injury
Spinal Cord Injury
Sponsors
Kessler Foundation
Seton Hall University
James J. Peters Veterans Affairs Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Wave Velocity (m/s) | 2 years | Determine average pulse wave velocity among the three groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Spinal Cord Injury: Spinal Cord Injury | 11 |
| 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
Spinal Cord Injury: Spinal Cord Injury | 11 |
| Able-bodied Control Ages between 21-70 | 11 |
| Total | 33 |
Baseline characteristics
| Characteristic | Cervical SCI | Thoracic SCI | Able-bodied Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 11 Participants | 33 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 13 | 43 years STANDARD_DEVIATION 11 | 45 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 11 Participants | 10 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 11 participants | 11 participants | 11 participants | 33 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 9 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Pulse Wave Velocity (m/s)
Determine average pulse wave velocity among the three groups.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervical SCI | Pulse Wave Velocity (m/s) | 8.81 m/s | Standard Deviation 1.91 |
| Thoracic SCI | Pulse Wave Velocity (m/s) | 7.36 m/s | Standard Deviation 1.58 |
| Able-bodied Control | Pulse Wave Velocity (m/s) | 5.53 m/s | Standard Deviation 0.95 |
Secondary
Norepinephrine (pg/ml)
Determine differences in plasma norepinephrine among the groups.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervical SCI | Norepinephrine (pg/ml) | 176.0 pg/mL | Standard Deviation 90 |
| Thoracic SCI | Norepinephrine (pg/ml) | 515.6 pg/mL | Standard Deviation 162.3 |
| Able-bodied Control | Norepinephrine (pg/ml) | 371.8 pg/mL | Standard Deviation 118.3 |
Secondary
Plasma Renin (pg/ml)
Determine differences in plasma renin among the groups
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervical SCI | Plasma Renin (pg/ml) | 24.9 pg/mL | Standard Deviation 13.9 |
| Thoracic SCI | Plasma Renin (pg/ml) | 21.9 pg/mL | Standard Deviation 18 |
| Able-bodied Control | Plasma Renin (pg/ml) | 16.0 pg/mL | Standard Deviation 7.4 |
Secondary
Systolic Blood Pressure (mmHg)
Determine differences in blood pressure among groups
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervical SCI | Systolic Blood Pressure (mmHg) | 95 mmHg | Standard Deviation 20 |
| Thoracic SCI | Systolic Blood Pressure (mmHg) | 125 mmHg | Standard Deviation 14 |
| Able-bodied Control | Systolic Blood Pressure (mmHg) | 128 mmHg | Standard Deviation 27 |