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临床试验/NCT04732975
NCT04732975暂停不适用

Mason Heart Study With Magnetocardiography

Genetesis Inc.1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
250
试验地点
1
主要终点
specificity and accuracy statistics

研究概览

简要总结

Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The Mason Heart Study-MCG (MHS-MCG) registry is designed to collect magnetocardiography (MCG) scans on a select group of healthy volunteers who work for the city of Mason, OH, with and without cardiac symptoms, illnesses, and/or risk factors. CardioFlux is used as a noninvasive MCG tool that analyzes and records the magnetic fields of the heart to detect various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 250 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years of age at the time of enrollment.

排除标准

  • < 18 years of age
  • Patients unable to fit into device
  • Non-ambulatory patients
  • Positive response on CardioFlux Pre-Screening Form
  • Patients with claustrophobia or unable to lie supine for 5 minutes
  • Pregnant women
  • Poor candidate for follow-up (e.g. no access to phone)

结局指标

主要结局

specificity and accuracy statistics

时间窗: 6 months

analyzing the specificity and accuracy of CardioFlux

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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