Trial Outcomes & Findings for RAAS and Arterial Stiffness in SCI (NCT NCT04510974)
NCT ID: NCT04510974
Last Updated: 2025-02-20
Results Overview
Determine average pulse wave velocity among the three groups.
Recruitment status
COMPLETED
Target enrollment
33 participants
Primary outcome timeframe
2 years
Results posted on
2025-02-20
Participant Flow
Participant milestones
| Measure |
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
|
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
|
Able-bodied Control
Ages between 21-70
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RAAS and Arterial Stiffness in SCI
Baseline characteristics by cohort
| Measure |
Cervical SCI
n=11 Participants
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
|
Thoracic SCI
n=11 Participants
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
|
Able-bodied Control
n=11 Participants
Ages between 21-70
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 13 • n=5 Participants
|
43 years
STANDARD_DEVIATION 11 • n=7 Participants
|
45 years
STANDARD_DEVIATION 13 • n=5 Participants
|
44 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDetermine average pulse wave velocity among the three groups.
Outcome measures
| Measure |
Cervical SCI
n=11 Participants
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
|
Thoracic SCI
n=11 Participants
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
|
Able-bodied Control
n=11 Participants
Ages between 21-70
|
|---|---|---|---|
|
Pulse Wave Velocity (m/s)
|
8.81 m/s
Standard Deviation 1.91
|
7.36 m/s
Standard Deviation 1.58
|
5.53 m/s
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 2 yearsDetermine differences in blood pressure among groups
Outcome measures
| Measure |
Cervical SCI
n=11 Participants
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
|
Thoracic SCI
n=11 Participants
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
|
Able-bodied Control
n=11 Participants
Ages between 21-70
|
|---|---|---|---|
|
Systolic Blood Pressure (mmHg)
|
95 mmHg
Standard Deviation 20
|
125 mmHg
Standard Deviation 14
|
128 mmHg
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 2 yearsDetermine differences in plasma renin among the groups
Outcome measures
| Measure |
Cervical SCI
n=11 Participants
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
|
Thoracic SCI
n=11 Participants
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
|
Able-bodied Control
n=11 Participants
Ages between 21-70
|
|---|---|---|---|
|
Plasma Renin (pg/ml)
|
24.9 pg/mL
Standard Deviation 13.9
|
21.9 pg/mL
Standard Deviation 18
|
16.0 pg/mL
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 2 yearsDetermine differences in plasma norepinephrine among the groups.
Outcome measures
| Measure |
Cervical SCI
n=11 Participants
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
|
Thoracic SCI
n=11 Participants
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
|
Able-bodied Control
n=11 Participants
Ages between 21-70
|
|---|---|---|---|
|
Norepinephrine (pg/ml)
|
176.0 pg/mL
Standard Deviation 90.0
|
515.6 pg/mL
Standard Deviation 162.3
|
371.8 pg/mL
Standard Deviation 118.3
|
Adverse Events
Cervical SCI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thoracic SCI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Able-bodied Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place