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| Name | Class |
|---|---|
| Kessler Foundation | OTHER |
| Seton Hall University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| Able-bodied Control | Ages between 21-70 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Injury | Other | Spinal Cord Injury |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave Velocity (m/s) | Determine average pulse wave velocity among the three groups. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure (mmHg) | Determine differences in blood pressure among groups | 2 years |
| Plasma Renin (pg/ml) | Determine differences in plasma renin among the groups |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatient individuals with SCI, flyers in town
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J Peters VAMC | The Bronx | New York | 10468 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Able-bodied Control | Ages between 21-70 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Thoracic SCI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pulse Wave Velocity (m/s) | Determine average pulse wave velocity among the three groups. | Posted | Mean | Standard Deviation | m/s | 2 years |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caitlyn Peters | James J Peters VA Medical Center | 9733243588 | cpeters@kesslerfoundation.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2020 | Jun 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D013119 | Spinal Cord Injuries |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C576348 | Creb3l2 protein, rat |
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| 2 years |
| Norepinephrine (pg/ml) | Determine differences in plasma norepinephrine among the groups. | 2 years |
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
| BG002 | Able-bodied Control | Ages between 21-70 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Able-bodied Control |
Ages between 21-70 |
|
|
| Secondary | Systolic Blood Pressure (mmHg) | Determine differences in blood pressure among groups | Posted | Mean | Standard Deviation | mmHg | 2 years |
|
|
|
| Secondary | Plasma Renin (pg/ml) | Determine differences in plasma renin among the groups | Posted | Mean | Standard Deviation | pg/mL | 2 years |
|
|
|
| Secondary | Norepinephrine (pg/ml) | Determine differences in plasma norepinephrine among the groups. | Posted | Mean | Standard Deviation | pg/mL | 2 years |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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 | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Able-bodied Control | Ages between 21-70 | 0 | 11 | 0 | 11 | 0 | 11 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |