跳至主要内容
临床试验/NCT01065896
NCT01065896已完成不适用

The Use of Non-invasive Multidetector Coronary Computed Tomography Imaging for the Assessment of Coronary Calcification in Persons With Spinal Cord Injury

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Quantification of coronary calcium

研究概览

简要总结

Although conventional risk factors for coronary heart disease (CHD) have been identified and routinely used to determine risk for CHD in the general population, a systematic approach to determine population-specific risk for CHD has not been performed prospectively in those with SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD are high serum concentrations of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), positive smoking history, and positive family history of premature CHD.

Coronary calcification (CAC) is a commonly occurring phenomenon that does not necessarily indicate significant obstructive disease. Studies have shown that a strong association exists between coronary calcification and coronary heart disease. The purpose of this study is to compare the CAC scores in persons with SCI with a historical control group of able-bodied persons from a national data base who will be matched for conventional risk factors for coronary artery disease (CAD) and to determine the relationship between CAC scores and conventional and emerging risk factors for CAD.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, 18 to 70 years of age;
  • Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of lesion or completeness of injury);
  • Concurrently participating in or previously completed protocol # 0454-06-073, "Risk Factors for Coronary Heart Disease in Spinal Cord Injury: conventional and emerging".

排除标准

  • Acute medical illness;
  • Pregnancy (as determined by a pregnancy test < 1 week of the study); and
  • The presence of a chronic disease (i.e., heart disease, pulmonary disease, etc.);
  • Inability to comply with breathing instructions.

结局指标

主要结局

Quantification of coronary calcium

时间窗: 2 years

次要结局

  • Determine the relationship between calcification scores and vascular reactivity(2 years)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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