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临床试验/NCT04166539
NCT04166539已完成不适用

Risk of Dementia and Heart Failure in Total Joint Arthroplasty

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2019年10月1日最近更新:
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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Maradit Kremers

Principal Investigator

Mayo Clinic

研究点 (1)

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