NCT04166539已完成不适用
Risk of Dementia and Heart Failure in Total Joint Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Brain MRI findings
研究概览
简要总结
The purpose of this research is to understand whether patients who previously had total hip or total knee replacement experience memory, thinking or heart problems. This study will help us determine if and how often these problems occur.
详细描述
At your first visit you will be asked to do the following.
- Sign this informed consent document.
- Questionnaire: You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.
- Interview: The interview will be performed by the study coordinator who is a member of the research team. It will take about 20-30 minutes to complete. You will be asked to answer questions about your general health, surgeries, medications, and your memory and thinking skills.
- Memory Interview: You will have an evaluation of your memory and thinking skills. You will answer questions and perform tasks that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
- Blood draw: Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.
- Magnetic Resonance Imaging (MRI) of your brain (optional): If you agree to participate, you will be asked to have MR imaging of your brain.
- Echocardiogram: You will be asked to have an echocardiogram of your heart.
- Follow-up visit in 2-3 years: You will be asked to return to Mayo for your second study visit in 2-3 years. At this visit, you will be asked to complete the same memory and thinking tests described for the first visit. You will also be asked to repeat the echocardiogram.
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 is willing to sign consent
- •Patients scheduled for revision surgery for osteolysis, aseptic loosening, or wear of TJA implants/ALTR.
- •MCSA (Mayo Clinic Study of Aging) patients with THA or TKA with at least 10 years since surgery.
排除标准
- •History of dementia
- •History of cardiomyopathy or heart failure
- •Revision for infection or fracture
- •Patient is pregnant
- •Patient has medication patches on
- •Patient has a pacemaker or defibrillator (ICD)
- •Patient has a deep brain stimulator (DBS)
- •Patient has a vagal neuro stimulator (VNS)
- •Patient has any other kind of neuro stimulator
- •Patient has aneurysm clips in their head
- •Patient has a tissue expander
- •Patient has had a gastrointestinal clip or pill camera inserted in the last 90 days
- •Patient has an esophageal reflux management system (LINX)
- •Patient has a cochlear (ear) or auditory implant
- •Patient has any implanted device (electronic or not) with magnets
- •Patient has an eye injury involving metal
- •Patient has allergy to contrast or dye
结局指标
主要结局
Brain MRI findings
时间窗: 1 year
imaging
Mild Cognitive Impairment
时间窗: 1 year
Cognitive impairment as assessed through interviews
Left ventricular dysfunction
时间窗: 1 year
heart dysfunction as assessed using echocardiography
次要结局
未报告次要终点
研究者
Hilal Maradit Kremers
Principal Investigator
Mayo Clinic
研究点 (1)
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