Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT01204632|
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : February 18, 2016
|Condition or disease|
|Spinal Cord Injury|
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.
- 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 :||Observational|
|Actual Enrollment :||74 participants|
|Official Title:||Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
- Body composition [ Time Frame: 1 visit ]The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.
- Carotid Intima-Media Thickness [ Time Frame: 1 visit ]Carotid intima-media thickness (IMT) measurements will be generated using B-mode external vascular ultrasound.
- 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.
- Atherosclerotic plaques [ Time Frame: 1 visit ]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.
- Area Under the Curve (AUC)for lipemia [ Time Frame: 1 visit ]Lipemia is assessed by the AUC for triglycerides during an oral glucose tolerance test.
- Area Under the Curve (AUC) for glycemia [ Time Frame: 1 visit ]Glycemia is assessed by the AUC for glucose and insulin during an oral glucose tolerance test.
- Area Under the Curve (AUC)for vascular inflammation [ Time Frame: 1 visit ]The pro-atherogenic inflammatory mediators are AUCs for C-reactive protein and Interleukin-6 during an oral glucose tolerance test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204632
|United States, Florida|
|The Miami Project to Cure Paralysis|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Mark S Nash, PhD||University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis|