跳至主要内容
临床试验/NCT05887453
NCT05887453招募中不适用

An Exploratory Clinical Study to Evaluate the Specificity of Magnetocardiogram in Atrial Fibrillation and the Prediction of Recurrence

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2023年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
1
主要终点
sensitivity and specificity

研究概览

简要总结

This is a prospective, observational clinical study with150 patients of persistent AF (trial group 1), 150 patients of paroxysmal AF (trial group 2), and 150 healthy subjects (control group). The trial is divided into two parts. The aim of first part is to evaluate the sensitivity and specificity of magnetocardiography on diagnosing persistent AF, and the second part is to evaluate the independent predictors of magnetocardiography on predicting recurrence of paroxysmal AF. The patients who had been diagnosed with AF in OPD or IPD will be included. After signing the informed consent letter, medical history of all subjects will be collected, including magnetic cardiogram, 12-lead electrocardiogram, holter electrocardiogram, cardiac ultrasound and blood tests. Patients with paroxysmal AF will be followed up for 3 months, and the recurrence of AF is the observation end point.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

sensitivity and specificity

时间窗: 24 hours

The sensitivity and specificity of magnetocardiography in the diagnosis of persistent AF

Independent predictors of recurrence of paroxysmal atrial fibrillation

时间窗: 3 months

A statistical model is used to obtain the magnetocardiographic parameters that could predict the recurrence of paroxysmal atrial fibrillation.

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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