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临床试验/NCT04739254
NCT04739254暂停不适用

Magnetocardiography Endocrine Registry

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
Accuracy statistics

研究概览

简要总结

Endocrine disorders like Type 2 diabetes mellitus (T2DM) represent complex cardiometabolic disease processes affecting approximately 462 million individuals worldwide and is associated with a two- to three-fold increase in cardiovascular mortality. Individuals with T2DM are at an increased risk of developing cardiovascular disease. Research has shown individuals with T2DM and no previous history of coronary artery disease are still at similar risk rates for cardiovascular events as patients with a prior myocardial infarction. The MAgenetoCardiography ENDOcrine Registry (MACENDOR) study is designed to collect CardioFlux scans on a select group of volunteers who are high-risk patients with endocrine disorders. CardioFlux is used as a noninvasive magnetocardiography (MCG) tool that analyzes and records the magnetic fields of the heart to screen volunteers for 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 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
  • Patients deemed at risk for cardiovascular disease from endocrine disorders

排除标准

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

结局指标

主要结局

Accuracy statistics

时间窗: 12 months

analyzing the accuracy of CardioFlux

Specificity statistics

时间窗: 12 months

analyzing the specificity of CardiFlux

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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