Spinal Cord Injury Clinical Trial
Official title:
Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
The purpose of this study is to develop and field-test new tools for diagnosis and hazard assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and to advance the evidence base with much needed information on CMR and cardiovascular disease (CVD) burden in people with SCI. These data can be used to develop screening guidelines for early identification and prevention of CMR in SCI, as well as targeted approaches to primary disease management.
Unlike current assessments utilizing lipid scores, the new system will be anchored in more
reliable measurements of cardiovascular disease (CVD) burden using contemporary surrogate
end points of coronary artery calcium (CAC) score, coronary CT angiography and carotid
intima media thickness (CIMT). By the end of the 5-year funding cycle we will develop an
updatable web-based cardiometabolic risk assessment tool (RISK) that will allow clinicians
and SCI consumers to quantify risk for a cardiovascular sentinel event (stroke, non-fatal
heart attack, or death) and will also provide a body mass index (BMI) table adjusted for
SCI.
Specific Aims:
1. Examine the relationships among surrogates of cardiovascular disease burden in persons
with SCI and established cardiometabolic risks.
2. Identify significant predictors of cardiometabolic risk (CMR) that are unique to
persons with specific levels of SCI.
3. Develop and validate SCI CMR assessment tool (RISK) based on cardiometabolic risk
scores.
4. Develop and validate an adjusted BMI table for SCI.
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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
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Phase 1 | |
| Recruiting |
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ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
|
N/A | |
| Completed |
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Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
| Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
| Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
| Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
| Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
| Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
| Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
| Completed |
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Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
| Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
| Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
| Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
| Completed |
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Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
| Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
| Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
| Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 | |
| Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 | |
| Completed |
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|
N/A | |
| Completed |
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|