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临床试验/NCT04739280
NCT04739280已完成不适用

Women's Assessed Cardiovascular Evaluation With MCG

Genetesis Inc.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Accuracy Statistics

研究概览

简要总结

Cardiovascular disease (CVD) is the number one cause of death for women over the age of 25, accounting for 1 of every 3 female deaths. Research has shown that while hypertension in women is less controlled, they are also less likely to be identified with ischemic heart disease and when diagnosed treated less aggressively than men. Moreover, women who are diagnosed with breast cancer have an increased risk for cardiovascular disease. The Women's Assessed Cardiovascular Evaluation with MCG (WACE-MCG) study is designed to collect CardioFlux scans on a select group of female volunteers who are Ms. Medicine patients. 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 200 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
Female
接受健康志愿者

入选标准

  • ≥ 18 years of age at the time of enrollment. Female Patients deemed at risk for cardiovascular disease (breast cancer survivors, patients referred to cardiologists, prior COVID-19 patients, etc.)

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) Prisoners

结局指标

主要结局

Accuracy Statistics

时间窗: 6 Months

analyzing the accuracy of CardioFlux

Specificity Statistics

时间窗: 6 months

analyzing the specificity 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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