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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Charbel Abi Khalil, MD,PhD
- Telefonnummer: +974 4492 8484
- E-Mail: cha2022@qatar-med.cornell.edu
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Participants will be recruited at Hamad Medical Corporation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sensitivity and specificity of the EDE CARDIO BIO-MAP scanner(in vivo) for detecting myocardial infarction
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sensitivity and specificity of the portable lab's immediate blood measurements (in vitro)
Zeitfenster: 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
Zeitfenster: Baseline
|
Accuracy = (true positives + true negatives) / all results; |
Baseline
|
|
Misclassification rate of the EDE scanner
Zeitfenster: Baseline
|
Misclassification rate = (false positives + false negatives) / all results; |
Baseline
|
|
Precision of the EDE scanner
Zeitfenster: Baseline
|
precision = true positives / (true positives + false positives) |
Baseline
|
|
Accuracy of the portable lab
Zeitfenster: Baseline
|
Accuracy = (true positives + true negatives) / all results; |
Baseline
|
|
Misclassification rate of the portable lab
Zeitfenster: Baseline
|
Misclassification rate = (false positives + false negatives) / all results; |
Baseline
|
|
Precision of the portable lab
Zeitfenster: Baseline
|
precision = true positives / (true positives + false positives) |
Baseline
|
|
Correlation Between EDE Scanner and Portable Laboratory Values for Cardiac Biomarkers
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in cardiac biomarker levels between initial assessment and 4-6 hour follow-up
Zeitfenster: 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
Zeitfenster: Baseline
|
Subgroup analysis of scanner sensitivity and specificity by sex |
Baseline
|
|
Diagnostic performance of the scanner by age group
Zeitfenster: Baseline
|
Subgroup analysis of scanner sensitivity and specificity by age group |
Baseline
|
|
Diagnostic performance of the scanner by symptom profile
Zeitfenster: Baseline
|
Subgroup analysis of scanner sensitivity and specificity by symptom profile. |
Baseline
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Charbel Abi Khalil, MD,PhD, Weill Cornell Medicine-Qatar
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 23-00017
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
ongoing discussion with the sponsor
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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