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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Heart Input Output Inc
Study ID
NCT07375810
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease (CAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • AI-ECG Analysis — DEVICE
    The AI-Analysis done on the ECGs in a retrospective fashion

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Jul 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
978 participants (estimated)

Arms

  • Arm: CT Angiogram
    This is the Cohort which received only Computed Tomography Angiography as a part of the study
  • Arm: Invasive Angiography
    This is the Cohort which received both Computed Tomography Angiography and Invasive Angiography as a part of the study
  • Arm: Enrollment Period 2
    This Cohort is the continuation of enrollment of invasive angiogram patients beyond the completion of the primary endpoint

Primary Outcome Measure

Sensitivity & Specificity [ Time Frame: Within 30 days of enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010
Hector Garcia, M.D
[email protected]
(202) 877-7000
Cena Research InstituteHoustonTexas77055
Asif Ali, MD
[email protected]
713-464-4140
Asif Ali, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
Medstar Washington Hospital Center· Washington D.C., DCCena Research Institute· Houston, TX

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