Health TrialsbyHealthPanel

Analysis of ECGio to Predict Coronary Stenosis Against a Mixed Reference Standard

ConditionCoronary Artery Disease (CAD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorHeart Input Output Inc

About this trial

The study objective is to evaluate the effectiveness of the ECGio algorithm in predicting clinically significant coronary artery disease . ECGio's diagnostic performance during the trial will be compared against an objective performance ¬criteria using a mixed reference standard of quantitative coronary angiography and quantitative coronary computed tomography angiography in patients a general adult population under suspicion of coronary artery disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years of age or older at time of data collection.

Patients with medical records stored in a digitized format.

Patients under suspicion of coronary artery disease (both suspicion of significant coronary artery disease as well as to rule out significant CAD) who present to the site with an electrocardiogram recorded up to 30 days prior to Coronary Computed Tomography Angiography.

Disqualifiers

Patients with acute coronary syndrome.

Patients who previously underwent coronary artery bypass grafting.

Patients whose electrocardiogram tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing.

Patients with prior percutaneous coronary intervention resulting in stenting.

Trial population

The study population will be made up of all-comers to Coronary Computed Tomography Angiography from each site taking up to the first 250, consecutive patients recruited for the analysis.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • AI-ECG Analysis

    Device

    The AI-Analysis done on the ECGs in a retrospective fashion

Treatment groups

978 Participants
are divided into 3 treatment groups
Group A: CT Angiogram1 intervention
Group B: Invasive Angiography1 intervention
Group C: Enrollment Period 21 intervention

Trial outcomes

Primary outcomes

1

Sensitivity & Specificity

The lower 95% bound of ECGio's sensitivity and specificity in patients who underwent invasive angiography or computed tomography angiography (Co-primary endpoints)

Time frame
Within 30 days of enrollment

Secondary outcomes

1

Sensitivity & Specificity

The lower 95% bound of ECGio's sensitivity and specificity in patients who underwent invasive angiography (Co-secondary endpoints) in enrollment period 2

Time frame
For the first 300 patients referred to invasive angiography through study completion, an average of 90 days
2

Demographic Performance

ECGio's predictive performance across different demographic groups (e.g Race, Sex, Risk Factors)

Time frame
For patients in the 30 days following computed tomography angiography
3

Angiographic Stenosis Prediction

The Root Mean Squared Error in predicting the greatest diameter stenosis per vessel (Left Main Artery, Left Anterior Descending Artery, Left Circumflex Artery, Right Coronary Artery)

Time frame
For the first 300 patients referred to invasive angiography through study completion, an average of 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Input Output Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: