Status:
COMPLETED
Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
Lead Sponsor:
University of Miami
Collaborating Sponsors:
MedStar National Rehabilitation Network
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Brief Summary
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 ev...
Detailed Description
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 coron...
Eligibility Criteria
Inclusion
- traumatic spinal cord injury between C4 and T12
- have a motor complete injury as classified as American Spinal Injury Association Impairment Scale (AIS) grade A or B
- injury for more than 1 year
- no known history of traumatic brain injury, cardiovascular disease or diabetes
- not currently taking any medications to treat cardiovascular disease or diabetes
- have multiple (i.e., 2+) of the following cardiometabolic risk factors:
- fasting triglyceride \> 150 mg/dL
- HDLC \< 40 mg/dL
- hs-CRP \> 3.0
- body fat (by DEXA) \>25% for males and 33% for females
Exclusion
- history of allergy or hypersensitivity to fish and/or nuts
- undergoing anticoagulant therapies
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01204632
Start Date
March 1 2010
End Date
December 1 2015
Last Update
February 18 2016
Active Locations (1)
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1
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136