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临床试验/NCT01325467
NCT01325467Unknown不适用

Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry

BSP Biological Signal Processing Ltd.3 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
900
试验地点
3
主要终点
CAD status

研究概览

简要总结

This will be a registry study that will enroll patients referred for an ECG treadmill test with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information will be recorded and analyzed automatically and simultaneous with the standard ECG signals by the HyperQ System. Results of subsequent tests performed on each patient will be collected and used to enhance the reliability of designating each patient as a CAD-negative (i.e., no significant coronary artery disease) or a CAD-positive (i.e., significant coronary artery disease).

研究设计

研究类型
Observational
观察模型
Case Only
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 or older
  • Referred for exercise MPI due to suspected coronary artery disease

排除标准

  • Acute Coronary Syndrome (Unstable angina/NSTEMI/STEMI)
  • Pre-excitation syndrome
  • QRS duration > 120 ms
  • Atrial Fibrillation or significant ventricular arrhythmia
  • Treatment with Digoxin
  • Pacemaker with 100% pacemaker dependence

结局指标

主要结局

CAD status

时间窗: one month follow up

The main goal of this registry will be to compare sensitivity, specificity, positive and negative predictive values of the HyperQ HFQRS analysis for detecting the presence of coronary artery disease to that of standard ECG analysis.

次要结局

未报告次要终点

研究者

发起方
BSP Biological Signal Processing Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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