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临床试验/NCT02725671
NCT02725671终止不适用

Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Accuracy of Identifying Patients With at Least One 50 Percent or Greater Coronary Artery Stenosis by CT Angiography

研究概览

简要总结

Cardiogoniometry is a technique to process and evaluate vectorcardiography from regular ECG acquisitions. Vectorcardiography has a long tradition in cardiology for providing comprehensive information on myocardial function and integrity. In recent years, computer assisted analysis has allowed automated interpretation of vectorcardiography with promising results in comparison to standard ECG for identifying patients with coronary heart disease. This study aims to investigate the utility of cardiogoniometry for noninvasively identifying patients who are at risk from coronary heart disease.

详细描述

Cardiogoniometry is a technique to process and evaluate vectorcardiography from regular ECG acquisitions. Vectorcardiography has a long tradition in cardiology for providing comprehensive information on myocardial function and integrity. Compared to standard electrocardiography, vectorcardiography has shown to be more sensitive to detect structural and ischemic heart disease. Unfortunately, the interpretation of vectorcardiography is complex which has hindered its widespread application. In recent years, computer assisted analysis has allowed automated interpretation of vectorcardiography with promising results in comparison to standard ECG for identifying patients with ischemic heart disease. However, the underlying mechanisms and threshold of altered cardiac vectors in the presence of coronary artery disease are not well understood. This research aims at exploring the relationship of computer assisted analysis of vectorcardiography with the presence, extent, severity, and location of coronary artery disease in comparison to standard ECG evaluation. Furthermore, the investigators intent to follow up enrolled patients for the occurrence of adverse cardiovascular events for correlation with test findings. These data will provide comprehensive information on the diagnostic performance of noninvasive, inexpensive evaluation of cardiac vector loops for identifying patients at risk from coronary artery disease. Specifically, the study aims to:

  1. Compare the diagnostic accuracy of cardiogoniometry with standard ECG for detecting coronary artery disease as assessed by CT angiography
  2. Investigate the relationship between abnormal cardiogoniometry findings and the extent/severity/location of coronary artery disease by CT angiography
  3. Compare the intermediate term prognosis of patients according to cardiogoniometry, standard ECG, and CT findings

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients age 18 or older who are referred for elective cardiac CT examination for evaluation of coronary artery disease

排除标准

  • hemodynamic instability
  • history of anaphylactic contrast reaction
  • inability of following breath hold instructions

结局指标

主要结局

Accuracy of Identifying Patients With at Least One 50 Percent or Greater Coronary Artery Stenosis by CT Angiography

时间窗: 30 days from CGM analysis

Area under curve (AUC) analysis is proposed to be used to determine the diagnostic accuracy of cardiogoniometry for detecting patients with coronary heart disease as defined by at least one 50% or greater stenosis on CT coronary angiography.

次要结局

  • Risk of Hospitalization(5 years after enrollment)
  • Accuracy of Identifying Patients With Any Coronary Atherosclerotic Disease by CT Angiography(30 days)
  • Incidence of Death at Follow up(5 years after enrollment)
  • Risk of Myocardial Infarction(5 years after enrollment)
  • Risk of Revascularization at Follow up(5 year after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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