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临床试验/NCT04290091
NCT04290091已完成不适用

Detection of Coronary Artery Disease With Micro Electro-Mechanical Sensors

Precordior Ltd1 个研究点 分布在 1 个国家目标入组 930 人开始时间: 2020年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
930
试验地点
1
主要终点
Coronary artery disease

研究概览

简要总结

This study aims to validate the sensor data of gyroscope and accelerometer in detection of hemodynamically significant CAD.

详细描述

Heart diseases are the most common cause of morbidity and mortality in the western world. Coronary artery disease (CAD) alone is estimated to affect 110 million people globally and resulted in 8.9 million deaths in 2015.

A hallmark phenomenon in the development of CAD is the formation of arterial stenoses eventually limiting the arterial circulation. Myocardial ischemia caused by the stenoses may present symptoms considered typical, i.e, angina pectoris chest pain, but the symptoms may vary up to an asymptomatic state. Estimating the pre-test likelihood of angiographically significant CAD (≥50% diameter stenotic CAD) is a fundamental component in the initial evaluation of symptomatic patients presenting with suspected CAD. This determination directly influences subsequent decisions for noninvasive diagnostic testing and treatment. However, studies have shown a relatively low prevalence of either ischemia or obstructive CAD on noninvasive imaging and invasive angiography (IA) in this population. Therefore, additional methods are needed to improve patient selection for such testing.

Mechanocardiography (MCG) assesses the condition of the heart by measuring the mechanical activity (cardiac muscle motion) of the heart from the surface of thorax. MCG can be measured with accelerometer and gyroscope which react to recoil and vibration caused my cardiac contraction.

This study aims to validate how the gyroscope and accelerometer derived parameters can identify patients with hemodynamically significant CAD in combined contrast computed tomography (CT) coronary angiography and positron emission tomography (PET) perfusion imaging in combination of high-sensitive troponin testing. The performance of different MCG algorithms will be tested offline as a head-to-head comparison with medical history, cardiovascular events, high-sensitive troponin values, coronary computed tomography angiography (CCTA) and PET scan results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Age > 18 years
  • Patients visiting hospital for suspected CAD and undergoing CCTA
  • Signed informed consent as an acceptance to participate to the trial

排除标准

  • informed consent not signed

结局指标

主要结局

Coronary artery disease

时间窗: Time of enrolment

CCTA results with optional myocardial PET perfusion imaging

次要结局

  • Coronary artery disease event(2 year after enrolment to the study)

研究者

发起方
Precordior Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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