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Determination of Specificity and Sensitivity in Detecting Myocardial Infarction Using the EDE CARDIO BIO-MAP Machine (CARDIO BIO-MAP)

2026年11月3日 更新者：Weill Cornell Medical College in Qatar

Determination of Specificity and Sensitivity in Detecting Myocardial Infarction Using the EDE CARDIO BIO-MAP Machine, the EDE CARDIO BIO-MAP Study

The goal of this observational study is to learn whether a non-invasive electromagnetic wave scanner (EDE CARDIO BIO-MAP) can help diagnose myocardial infarction (heart attack) in adults (18 years and older) who come to the emergency department with chest pain and suspected myocardial infarction. The main questions it aims to answer are:

  • How sensitive and specific is the EDE scanner in diagnosing myocardial infarction (MI) compared with standard blood tests (e.g., cardiac troponin)?
  • How sensitive and specific are the immediate blood measurements from a portable lab device compared with conventional hospital laboratory measurements? Researchers will compare the results of the EDE scanner and the portable lab with standard hospital blood test results and the final clinical diagnosis to see how accurately each detects MI.

Participants will:

  • Have a research visit (30 minutes to 1 hour) during their emergency care, including a quick scan with the Exponential Deep Examination (EDE) device (attached to a phone or tablet) and a small research blood sample tested on a portable lab device
  • Repeat the scan and blood sample 4 to 6 hours later, only if a second blood draw is already needed for their clinical care
  • Answer questions about their medical and social history, and allow the study team to collect relevant results from their medical record Scanner results will not be shared with participants or used for their clinical care.

研究概览

地位

尚未招聘

条件

详细说明

Myocardial infarction is a leading cause of death and disability worldwide. Current diagnosis relies on clinical assessment, electrocardiogram, and blood measurement of cardiac biomarkers such as troponin. Faster, non-invasive diagnostic tools could be especially valuable in the emergency setting, where timely intervention is critical.

The Exponential Deep Examination Cardio Bio-Map is a non-invasive device, classified as Class 1 under the European Conformity marking system, that analyzes passive electromagnetic signals (0.1 to 300 gigahertz) using artificial intelligence to measure cardiac biomarkers without a blood draw. Results are available within 50 milliseconds. The device does not collect or store patient data. It produces an immediate printed report, and all data processing occurs locally within Qatar. During the COVID-19 pandemic, the same technology detected the SARS-CoV-2 virus with a specificity of 95.62% and a sensitivity of 93.71% compared with polymerase chain reaction testing and antibody testing. This study will evaluate whether the device can screen for myocardial infarction through measurement of cardiac biomarkers, both in biological samples (in vitro, using a portable laboratory device) and directly in patients (in vivo, using the scanner).

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants will be recruited at Hamad Medical Corporation

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Adults presenting to the emergency room for acute chest pain.
  • English or Arabic speakers.

Exclusion Criteria:

  • Pregnancy (self-reported).
  • Adults with cognitive disorders.
  • Unconscious patients.
  • Citizens from countries where the General Data Protection Regulation (GDPR) applies, due to regulatory constraints.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Sensitivity and specificity of the EDE CARDIO BIO-MAP scanner(in vivo) for detecting myocardial infarction
大体时间：Baseline

Sensitivity (true positives / [true positives + false negatives]) and specificity (true negatives / [true negatives + false positives]) of the scanner in emergency room patients with suspected myocardial infarction, compared with standard hospital laboratory results (cardiac troponin, creatine kinase-myocardial band, myoglobin, B-type natriuretic peptide, N-terminal pro-B-type natriuretic peptide) and the final clinical diagnosis in the medical record.
Baseline

次要结果测量

结果测量
措施说明
大体时间
Sensitivity and specificity of the portable lab's immediate blood measurements (in vitro)
大体时间：Baseline

Sensitivity and specificity of the portable lab's immediate blood measurements for myocardial infarction, compared with conventional hospital laboratory measurements, using a confusion matrix.
Baseline
Accuracy of the EDE scanner
大体时间：Baseline

Accuracy = (true positives + true negatives) / all results;
Baseline
Misclassification rate of the EDE scanner
大体时间：Baseline

Misclassification rate = (false positives + false negatives) / all results;
Baseline
Precision of the EDE scanner
大体时间：Baseline

precision = true positives / (true positives + false positives)
Baseline
Accuracy of the portable lab
大体时间：Baseline

Accuracy = (true positives + true negatives) / all results;
Baseline
Misclassification rate of the portable lab
大体时间：Baseline

Misclassification rate = (false positives + false negatives) / all results;
Baseline
Precision of the portable lab
大体时间：Baseline

precision = true positives / (true positives + false positives)
Baseline
Correlation Between EDE Scanner and Portable Laboratory Values for Cardiac Biomarkers
大体时间：Baseline

Pearson or Spearman correlation coefficient between scanner and portable lab values for cardiac biomarkers : Troponin T, Troponin I, Myoglobin, B-type Natriuretic Peptide, NT-proBNP, and Creatine Kinase-MB.
Baseline
Predictive power of each cardiac biomarker for myocardial infarction
大体时间：Baseline

Logistic regression, area under the receiver operating characteristic curve, and optimal diagnostic cutoffs for each cardiac biomarker: Troponin T, Troponin I, Myoglobin, B-type Natriuretic Peptide, NT-proBNP, and Creatine Kinase-MB.
Baseline

其他结果措施

结果测量
措施说明
大体时间
Change in cardiac biomarker levels between initial assessment and 4-6 hour follow-up
大体时间：Baseline and 4-6 hours after initial assessment

Change in cardiac biomarker levels( Troponin T, Troponin I, Myoglobin, B-type Natriuretic Peptide, NT-proBNP, and Creatine Kinase-MB) between the initial assessment and the follow-up, in participants who have a second clinical blood draw.
Baseline and 4-6 hours after initial assessment
Diagnostic performance of the scanner by sex
大体时间：Baseline

Subgroup analysis of scanner sensitivity and specificity by sex
Baseline
Diagnostic performance of the scanner by age group
大体时间：Baseline

Subgroup analysis of scanner sensitivity and specificity by age group
Baseline
Diagnostic performance of the scanner by symptom profile
大体时间：Baseline

Subgroup analysis of scanner sensitivity and specificity by symptom profile.
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Weill Cornell Medical College in Qatar

合作者

Hamad Medical Corporation

调查人员

  • 首席研究员：Charbel Abi Khalil, MD,PhD、Weill Cornell Medicine-Qatar

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2029年6月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年10月22日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 23-00017

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

ongoing discussion with the sponsor

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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