- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204632
Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
Study Overview
Status
Conditions
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 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:
- Examine the relationships among surrogates of cardiovascular disease burden in persons with SCI and established cardiometabolic risks.
- Identify significant predictors of cardiometabolic risk (CMR) that are unique to persons with specific levels of SCI.
- Develop and validate SCI CMR assessment tool (RISK) based on cardiometabolic risk scores.
- Develop and validate an adjusted BMI table for SCI.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
- The Miami Project to Cure Paralysis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- history of allergy or hypersensitivity to fish and/or nuts
- undergoing anticoagulant therapies
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: 1 visit
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The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.
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1 visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Carotid Intima-Media Thickness
Time Frame: 1 visit
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Carotid intima-media thickness (IMT) measurements will be generated using B-mode external vascular ultrasound.
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1 visit
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Coronary Artery Calcium
Time Frame: 1 visit
|
Non-contrast cardiac CT will be used to measure coronary artery calcium, as the presence of any calcium detected in the coronary tree is diagnostic of atherosclerosis.
The volume of calcium is quantified, providing a score of plaque burden analogous to a physiologic stress test.
Coronary calcium scores directly correlate with risk of cardiac events, with higher scores indicating greater plaque burden and greater risk of cardiac events.
|
1 visit
|
Atherosclerotic plaques
Time Frame: 1 visit
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Noninvasive CT angiography will be used in visualizing both calcified and non-calcified atherosclerotic plaques.
This technique provides much finer anatomic detail and provides an opportunity to further identify latent atherosclerosis risk through the detection of both calcified and noncalcified atherosclerosis.
|
1 visit
|
Area Under the Curve (AUC)for lipemia
Time Frame: 1 visit
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Lipemia is assessed by the AUC for triglycerides during an oral glucose tolerance test.
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1 visit
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Area Under the Curve (AUC) for glycemia
Time Frame: 1 visit
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Glycemia is assessed by the AUC for glucose and insulin during an oral glucose tolerance test.
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1 visit
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Area Under the Curve (AUC)for vascular inflammation
Time Frame: 1 visit
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The pro-atherogenic inflammatory mediators are AUCs for C-reactive protein and Interleukin-6 during an oral glucose tolerance test.
|
1 visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark S Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMP-MN-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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