Rheumatic Heart DiseaseSHIELD 1NCT07599956
Artificial Intelligence to Scale Early Rheumatic Heart Disease Detection
A study testing AI assisted echocardiography in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- AI assisted echocardiography
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2026to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employed at a participating ADUNU facility
- Holds a designated role in the ADUNU program as a nurse screener
Who cannot join
- None. The pragmatic trial design includes all eligible staff at participating facilities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Uganda Heart Institute
Kampala
Doreen Nakagaayi, +256 780770785, dnakagaayi@gmail.com
Doreen Nakagaayi
About this study
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.
- Conditions
- Rheumatic Heart Disease
- Being tested
- AI assisted echocardiography
- Keywords
- Rheumatic heart disease, Artificial Intelligence, Deep Learning, Machine Learning
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI assisted echocardiographyDiagnostic test
Continue standard of care with AI-assisted echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Standard non-AI echocardiography | No intervention | In the Standard non-AI Echocardiography arm, participants will receive the current standard of care under the ADUNU program, which includes a single parasternal long-axis view with black-and-white and color Doppler imaging. Providers have been trained to recognize mitral regurgitation greater than 1.5 or 2 cm, any aortic insufficiency, qualitatively reduced left ventricular systolic function, and pericardial effusion. Detection of any of these findings constitutes a screen positive, prompting referral for a confirmatory echocardiogram. |
| RADAR-AI-assisted echocardiography | Experimental | In the RADAR Echocardiography arm, participants will undergo AI-assisted screening according to the well-established RADAR protocol including the same image acquisition protocol but interpreted by the tablet-based software based on two independent AI algorithms 1) RHD positive or negative and 2) mitral regurgitation jet length. Positive findings from either algorithm constitutes a screen positive. Providers may also refer for other concerns. Receives: Diagnostic Test: AI assisted echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Provider RHD Screening
The number of correctly identified (positive or negative) screenings divided by the total number of exams.
Measured: 1 year
Secondary outcomes (1)
Interpretation Sensitivity
The number of correctly identified positive screening exams divided by the sum of correctly identified positive and incorrectly identified negative exams.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following informed consent, providers will be randomized using the computer-generated online randomization module in REDCap, housed at Cincinnati Children's. Randomization will use permuted blocks with no stratification. Of the 52 providers enrolled, 26 will be assigned to each study arm-AI-assisted echocardiography or standard non-AI echocardiography-in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Heart Institute, Ochsner Health System, Vanderbilt University Medical Center, Children's National Health Center
- Responsible party
- Sponsor
- Investigators
- Andrea Beaton, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599956
- Sponsor's protocol ID
- 2026-0304
- Acronym
- SHIELD 1
- Status last verified
- Oct 2026
- First submitted
- 14 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No