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Not yet recruitingNCT07926230CARDIO BIO-MAPUpdated Nov 9, 2026

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

An observational study in Myocardial Infarction, sponsored by Weill Cornell Medical College in Qatar. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Weill Cornell Medical College in Qatar · Observational

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the detailed description

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).

02

Conditions studied

  • Myocardial Infarction

Keywords

  • chest pain
  • Diagnostic accuracy
  • cardiac troponin
  • point-of-care testing
03

In context

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

This study's planned enrollment of 200 is below the median of 568 across 814 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Weill Cornell Medical College in Qatar is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be recruited at Hamad Medical Corporation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of the EDE CARDIO BIO-MAP scanner(in vivo) for detecting myocardial infarction

    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.

    Time frame: Baseline

Secondary outcomes

  1. Sensitivity and specificity of the portable lab's immediate blood measurements (in vitro)

    Sensitivity and specificity of the portable lab's immediate blood measurements for myocardial infarction, compared with conventional hospital laboratory measurements, using a confusion matrix.

    Time frame: Baseline

  2. Accuracy of the EDE scanner

    Accuracy = (true positives + true negatives) / all results;

    Time frame: Baseline

  3. Misclassification rate of the EDE scanner

    Misclassification rate = (false positives + false negatives) / all results;

    Time frame: Baseline

  4. Precision of the EDE scanner

    precision = true positives / (true positives + false positives)

    Time frame: Baseline

  5. Accuracy of the portable lab

    Accuracy = (true positives + true negatives) / all results;

    Time frame: Baseline

  6. Misclassification rate of the portable lab

    Misclassification rate = (false positives + false negatives) / all results;

    Time frame: Baseline

  7. Precision of the portable lab

    precision = true positives / (true positives + false positives)

    Time frame: Baseline

  8. Correlation Between EDE Scanner and Portable Laboratory Values for Cardiac Biomarkers

    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.

    Time frame: Baseline

  9. Predictive power of each cardiac biomarker for myocardial infarction

    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.

    Time frame: Baseline

Other outcomes

  1. Change in cardiac biomarker levels between initial assessment and 4-6 hour follow-up

    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.

    Time frame: Baseline and 4-6 hours after initial assessment

  2. Diagnostic performance of the scanner by sex

    Subgroup analysis of scanner sensitivity and specificity by sex

    Time frame: Baseline

  3. Diagnostic performance of the scanner by age group

    Subgroup analysis of scanner sensitivity and specificity by age group

    Time frame: Baseline

  4. Diagnostic performance of the scanner by symptom profile

    Subgroup analysis of scanner sensitivity and specificity by symptom profile.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — ongoing discussion with the sponsor

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07926230
Lead sponsor
Weill Cornell Medical College in Qatar
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Jun 2029 (estimated)
Last update
Nov 9, 2026

Study contacts

Charbel Abi Khalil, MD,PhD
Contact
cha2022@qatar-med.cornell.edu
+974 4492 8484
Charbel Abi Khalil, MD,PhD
principal investigator · Weill Cornell Medicine-Qatar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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