Determination of Specificity and Sensitivity in Detecting Myocardial Infarction Using the EDE CARDIO BIO-MAP Machine (CARDIO BIO-MAP)
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.
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Charbel Abi Khalil, MD,PhD
- 電話番号：+974 4492 8484
- メール：cha2022@qatar-med.cornell.edu
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Participants will be recruited at Hamad Medical Corporation
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity and specificity of the EDE CARDIO BIO-MAP scanner(in vivo) for detecting myocardial infarction
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity and specificity of the portable lab's immediate blood measurements (in vitro)
時間枠：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
時間枠：Baseline
|
Accuracy = (true positives + true negatives) / all results; |
Baseline
|
|
Misclassification rate of the EDE scanner
時間枠：Baseline
|
Misclassification rate = (false positives + false negatives) / all results; |
Baseline
|
|
Precision of the EDE scanner
時間枠：Baseline
|
precision = true positives / (true positives + false positives) |
Baseline
|
|
Accuracy of the portable lab
時間枠：Baseline
|
Accuracy = (true positives + true negatives) / all results; |
Baseline
|
|
Misclassification rate of the portable lab
時間枠：Baseline
|
Misclassification rate = (false positives + false negatives) / all results; |
Baseline
|
|
Precision of the portable lab
時間枠：Baseline
|
precision = true positives / (true positives + false positives) |
Baseline
|
|
Correlation Between EDE Scanner and Portable Laboratory Values for Cardiac Biomarkers
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in cardiac biomarker levels between initial assessment and 4-6 hour follow-up
時間枠：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
時間枠：Baseline
|
Subgroup analysis of scanner sensitivity and specificity by sex |
Baseline
|
|
Diagnostic performance of the scanner by age group
時間枠：Baseline
|
Subgroup analysis of scanner sensitivity and specificity by age group |
Baseline
|
|
Diagnostic performance of the scanner by symptom profile
時間枠：Baseline
|
Subgroup analysis of scanner sensitivity and specificity by symptom profile. |
Baseline
|
協力者と研究者
捜査官
- 主任研究者：Charbel Abi Khalil, MD,PhD、Weill Cornell Medicine-Qatar
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 23-00017
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
ongoing discussion with the sponsor
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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