Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
1 other identifier
observational
74
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 16, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 18, 2016
February 1, 2016
5.8 years
September 16, 2010
February 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Body composition
The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.
1 visit
Secondary Outcomes (6)
Carotid Intima-Media Thickness
1 visit
Coronary Artery Calcium
1 visit
Atherosclerotic plaques
1 visit
Area Under the Curve (AUC)for lipemia
1 visit
Area Under the Curve (AUC) for glycemia
1 visit
- +1 more secondary outcomes
Eligibility Criteria
Community sample of healthy persons with spinal cord injury
You may qualify if:
- 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
You may not qualify if:
- history of allergy or hypersensitivity to fish and/or nuts
- undergoing anticoagulant therapies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- MedStar National Rehabilitation Networkcollaborator
Study Sites (1)
The Miami Project to Cure Paralysis
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S Nash, PhD
University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 16, 2010
First Posted
September 17, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 18, 2016
Record last verified: 2016-02