Mason Heart Study With Magnetocardiography
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
- 是
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
