Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Body composition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •history of allergy or hypersensitivity to fish and/or nuts
- •undergoing anticoagulant therapies
结局指标
主要结局
Body composition
时间窗: 1 visit
The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.
次要结局
- 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)
- Area Under the Curve (AUC)for vascular inflammation(1 visit)
研究者
Mark S. Nash, Ph.D., FACSM
Professor
University of Miami