Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Echo - Left Ventricular Ejection Fraction
研究概览
简要总结
The purpose of this research is to investigate whether patients who previously had endoprosthesis surgery experience memory, thinking, or heart problems. It will also help determine how often these problems occur.
详细描述
At your first visit you will be asked to do the following:
- Sign the consent document.
- Patient Interview: An interview will be conducted by the study coordinator on the research team. They will ask your past surgical history, health history, medications, and your cognition.
- Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
- Memory Interview: You will be evaluated on your memory and thinking skills three total times. One to determine baseline, and then repeated at one year and two years. You will answer questions that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
- Blood Draw: You will have a blood draw three times (4.2-5 tablespoons) to determine your baseline, 1 year, and 2 year research results.
6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient has an endoprosthesis after extremity malignancy
排除标准
- •Current fracture or infection around the endoprosthesis
- •Patient is pregnant
结局指标
主要结局
Echo - Left Ventricular Ejection Fraction
时间窗: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in LV ejection fraction as a percent.
Chromium Metal Levels
时间窗: Chromium level will be measured at baseline, 1 year, and 2 years
The change in chromium blood ion levels will be measured in ng/mL.
Titanium Metal Levels
时间窗: Titanium level will be measured at baseline, 1 year, and 2 years
The change in titanium blood ion levels will be measured in ng/mL.
Echo - Left Ventricular Mass
时间窗: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in LV Mass in grams.
Echo - Heart Hypertrophy
时间窗: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.
Cobalt Metal Levels
时间窗: Cobalt level will be measured at baseline, 1 year, and 2 years
The change in cobalt blood ion levels will be measured in ng/mL.
次要结局
- Psychometrist Testing - Memory Score(Testing will occur at baseline, 1 year, and 2 years.)
- Psychometrist Testing - Intelligence Score(Testing will occur at baseline, 1 year, and 2 years.)