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临床试验/NCT01150825
NCT01150825Unknown不适用

Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction

BSP Biological Signal Processing Ltd.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Diagnosis of Acute Myocardial Infarction

研究概览

简要总结

The primary objective of this study is to characterize the morphological patterns of high frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI), including STEMI and NSTEMI, compared to patients without AMI.

详细描述

Chest pain is one of the leading reasons of hospital emergency department (ED) visits worldwide. In the US, approximately 6 million people annually undergo evaluation in the ED for acute chest pain. Despite the wealth of knowledge available about acute coronary syndrome (ACS), this condition continues to be among the most difficult to predict or diagnose. Misdiagnoses may lead to discharge of patients with ACS, who should have been admitted as well as costly unnecessary hospitalizations of patients who do not have ACS.

More than 2/3 of the patients with ACS have unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Conventional ECG has low sensitivity of less than 50% in diagnosing these conditions. As the initial ECG in the ED is often non-diagnostic in ACS patients, the diagnosis of ST-elevation myocardial infarction (STEMI) during its early stages may also be difficult.

Analysis of high-frequency QRS components (HFQRS), which quantifies changes in the depolarization phase of the cardiac cycle, has been previously reported to be a sensitive method for detection of demand ischemia. Preliminary studies have shown that HFQRS-derived indices can also identify supply ischemia caused by prolonged balloon occlusion, and transient ischemic episodes in patients with chest pain.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 40 years (men and women)
  • Time from onset of chest pain ≤ 12h
  • AMI confirmed by biomarkers
  • Clinical or electrocardiographic evidence of ischemia during recording
  • Signed an informed consent

排除标准

  • Prior CABG
  • pre-excitation syndrome (e.g. WP)
  • Atrial Fibrillation or significant ventricular arrhythmia
  • BBB, intraventricular conduction delay or QRS duration > 120 ms
  • Implanted pacemaker or defibrillator
  • Left-ventricular hypertrophy

结局指标

主要结局

Diagnosis of Acute Myocardial Infarction

时间窗: Prior to hospitalization release

The primary end-point of the study is diagnosis of acute myocardial infarction, based on cardiac biomarkers, ECG changes clinical symptoms and coronary angiography.

次要结局

  • HFQRS analysis for detecting NSTEMI(Post data processing)

研究者

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

研究点 (1)

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