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NCT Number: NCT07599956

Artificial Intelligence to Scale Early Rheumatic Heart Disease Detection

The main goal of this project is to see if RADAR (Rapid AI-assisted Detection and Analysis of Rheumatic heart disease), which is a machine and deep-learning AI model, can help make rheumatic heart disease (RHD) screening easier to expand. Specifically, the project will test whether RADAR can screen as accurately-or more accurately-than current methods, and whether it can be used effectively in different low-resource settings. The aim is to show that RADAR could be adopted and used widely around the world.

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Key information

Conditions

Rheumatic Heart Disease Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Gram-Positive Bacterial Infections Heart Diseases Infections Rheumatic Fever Streptococcal Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Employed at a participating ADUNU facility
  • Holds a designated role in the ADUNU program as a nurse screener

Exclusion criteria

  • None. The pragmatic trial design includes all eligible staff at participating facilities.

Treatment and study plan

AI assisted echocardiography

Diagnostic Test

Continue standard of care with AI-assisted echocardiography

Primary outcomes

  1. Accuracy of Provider RHD Screening

    Time frame: 1 year

    The number of correctly identified (positive or negative) screenings divided by the total number of exams.

Secondary outcomes

  1. Interpretation Sensitivity

    Time frame: 6 months

    The number of correctly identified positive screening exams divided by the sum of correctly identified positive and incorrectly identified negative exams.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabella Brigham

CONTACT

[email protected]

513-517-1307

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Children's National Health Center
  • Ochsner Health System
  • Uganda Heart Institute
  • Vanderbilt University Medical Center

Registry information

Acronym: SHIELD 1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 20, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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