Identification of Heart Failure Patients by Seismocardiography; a Comparison With Echocardiography and Brain Natriuretic Peptide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure.
研究概览
简要总结
The aim of the current study is to develop and validate an algorithm based on seismocardiography recordings to detect heart failure. Echocardiography will be used as the golden standard for defining patients with heart failure.
详细描述
Seismocardiography is inspired from methods for the analysis of seismic activity and can be used to describe the heart's movements using a specially developed sensor placed on the patient's chest. The project aims to describe the motion of the heart using automated computer analysis of the seismocardiography signal for development of a simple method for the analysis of myocardial performance.
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
- 否
入选标准
- •Male or female, aged 18 years or older
- •Clinically suspected heart failure, and referred to an outpatient clinic
- •Be able and willing to comply with the clinical investigational plan
- •Have signed the informed consent form
排除标准
- •Known atrial fibrillation
- •Acute coronary syndrome
- •Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD)
- •Implanted electronic equipment in the area above and around the heart
- •Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process)
- •Pregnancy
- •Extension study:
- •Inclusion criteria
- •Male or female, aged 18 years or older
- •Newly diagnosed HFREF
- •Be able and willing to comply with the clinical investigational plan
- •Have signed the informed consent form
- •Exclusion criteria
- •Known atrial fibrillation
- •Acute coronary syndrome
- •Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD)
- •Implanted electronic equipment in the area above and around the heart
- •Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process)
结局指标
主要结局
Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure.
时间窗: 1 day
Heart failure defined as heart failure with reduced ejection fraction, heart failure with mid-range ejection fraction and heart failure with preserved ejection fraction combined.
次要结局
- Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography and NT-proBNP, respectively, in detection of heart failure with reduced ejection fraction(1 day)
- Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure with mid-range ejection fraction.(1 day)
- Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure with preserved ejection fraction.(1 day)
- Adverse events related to the CADScor seismo device.(1 day)