Trial Outcomes & Findings for A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury. (NCT NCT00248807)
NCT ID: NCT00248807
Last Updated: 2025-02-25
Results Overview
Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
acute testing
Results posted on
2025-02-25
Participant Flow
Recruitment has been completed.
All subjects recruited completed all testing procedures.
Participant milestones
| Measure |
Subjects With Spinal Cord Injury (SCI)
Subjects with SCI underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
|
Subjects Without SCI (Non-SCI)
Subjects without SCI (non-SCI) underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
11
|
|
Overall Study
COMPLETED
|
19
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury.
Baseline characteristics by cohort
| Measure |
Subjects With Spinal Cord Injury
n=19 Participants
Subjects with spinal cord injury underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
|
Non-spinal Cord Injured Subjects
n=11 Participants
Non-spinal cord injured subjects underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
|
Total
n=30 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
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 11 • n=5 Participants
|
35 years
STANDARD_DEVIATION 12 • n=7 Participants
|
39 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
11 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: acute testingPopulation: convenience sample
Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention
Outcome measures
| Measure |
ARM 3
n=19 Participants
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
|
ARM 1
n=19 Participants
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug
|
ARM 2
n=11 Participants
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug
|
ARM 4
n=11 Participants
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
|
|---|---|---|---|---|
|
Systolic Blood Pressure
|
119 mmHg
Standard Deviation 26
|
123 mmHg
Standard Deviation 37
|
125 mmHg
Standard Deviation 15
|
122 mmHg
Standard Deviation 14
|
SECONDARY outcome
Timeframe: acute testingMeasurement of middle cerebral artery blood flow velocity supine and during head-up tilt
Outcome measures
| Measure |
ARM 3
n=19 Participants
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
|
ARM 1
n=19 Participants
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug
|
ARM 2
n=11 Participants
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug
|
ARM 4
n=11 Participants
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
|
|---|---|---|---|---|
|
Cerebral Blood Flow
|
46.93 cm/sec
Standard Deviation 7.66
|
45.95 cm/sec
Standard Deviation 8.71
|
42.52 cm/sec
Standard Deviation 15.69
|
37.38 cm/sec
Standard Deviation 4.44
|
Adverse Events
ARM 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARM 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARM 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARM 4
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
Dr. Jill M. Wecht; Principal Investigator
James J Peters VAMC
Phone: 718 584-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place