AI eyes hidden heart condition: could algorithms catch what doctors miss?
NCT ID NCT07062848
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This study is testing whether artificial intelligence can detect transthyretin amyloid cardiomyopathy (ATTR-CM), a serious and often underdiagnosed heart condition, earlier than usual. Researchers will use AI algorithms to analyze routine ECGs and heart ultrasounds from up to 1.5 million people aged 50 to 95 across diverse US health systems. The goal is to see how common the condition really is and whether the AI tools can reliably flag it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an artificial intelligence toolkit that analyzes ECGs and ultrasounds to detect signs of transthyretin amyloid cardiomyopathy
- What this could lead to
- If successful, this AI approach could enable earlier, faster detection of a underdiagnosed heart condition, potentially improving outcomes for thousands of patients.
- What could go wrong
- This is an observational study, not a treatment trial. The AI algorithms may not perform equally well across all populations or healthcare settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,500,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will include US adults ages 50-95 with at least one retrievable ECG and/or 2D echo file from HER.
- Ages
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50 to 95 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Broad inclusion and exclusion criteria across all 3 objectives: Inclusion Criteria: * Age 50-95 * At least one retrievable ECG and/or 2D echo file (DICOM or equivalent video file) from EHR. Exclusion Criteria: * Unavailable key demographics (age, gender, race, ethnicity) * Individuals who have opted out of research studies Objective-specific inclusion and exclusion criteria: Primary Objective: Additional exclusion criteria: * For subgroup analyses: when evaluating the prevalence of probable ATTR-CM status across demographic groups, we will exclude those with missing baseline demographic information (age, sex, race, geographic region). Secondary Objective 1: Additional inclusion criteria: * 'Cases': ATTR-CM diagnosis defined by ICD-10 codes (Table 1) OR abnormal bone scintigraphy testing consistent with ATTR-CM OR treatment with an approved transthyretin stabilizer or other ATTR-CM-specific therapy * 'Controls': any individuals not meeting the case definition. In these participants, we will consider all eligible ECG, POCUS, or TTE studies performed up to 12 months before diagnosis (first date of ICD code appearance, abnormal bone scintigraphy or treatment onset, whichever happened first) and any time after. 'Controls' will be drawn from ECGs, POCUS, or TTE studies performed in individuals not meeting the 'case' criteria above, including individuals who have never undergone dedicating testing or those who underwent e.g., bone scintigraphy, but with negative (or equivocal) findings. Secondary Objective 2: Additional inclusion criteria: * Having at least two years of follow-up time between the index test (ECG, POCUS, or TTE) and the date of analysis. * Having at least one healthcare encounter every two years across care settings from their first entry into the cohort through death or end of the follow-up period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Henry Ford Health
Detroit, Michigan, 48202, United States
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Houstin Methodist
Houston, Texas, 77030, United States
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Medical University of South Carolina (MUSC) Health
Charleston, South Carolina, 29425, United States
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Montefiore
The Bronx, New York, 10467, United States
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Mount Sinai
New York, New York, 10029, United States
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Providence Health
Tigard, Oregon, 97224, United States
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The University of Chicago
Chicago, Illinois, 60637, United States
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of California - San Francisco (UCSF) Health
San Francisco, California, 94143, United States
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University of Virginia School of Medicine
Charlottesville, Virginia, 22903, United States
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University of Washington Medicine
Seattle, Washington, 98195, United States
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Yale New Haven Health System
New Haven, Connecticut, 06519, United States
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