AI-ECG + Cardiac Ultrasound for Heart Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new ways to detect heart disease early using advanced technologies like AI-enhanced ECGs (tests that measure heart activity) and focused cardiac ultrasounds (detailed heart images). The researchers aim to assess the effectiveness of these methods in various groups, including pregnant women, young adults, and community-dwelling adults. Suitable participants may include young adults living in Minnesota, adults over 30 without pacemakers, and pregnant women receiving specific obstetric care. The trial seeks to determine if these tests can quickly and accurately identify heart issues, potentially improving heart care. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could transform early heart disease detection.
What prior data suggests that this AI-ECG and cardiac ultrasound method is safe for heart disease screening?
Research has shown that the 12-lead AI-ECG is generally safe and easy to use. One study found positive results for this technology without major safety concerns. It plays a crucial role in diagnosing heart issues, providing important information without reported major side effects.
Similarly, the 6-lead AI-ECG has proven very accurate in detecting heart problems. Although the study primarily assessed its effectiveness, no major safety issues were reported, indicating its safety.
Focused Cardiac Ultrasound is also considered safe. Studies across the country have found that serious problems from ultrasound procedures are rare, making it generally safe for heart screenings.
Overall, previous research has shown that the treatments in this study are well-tolerated, with no major safety issues reported.12345Why are researchers excited about this trial?
Researchers are excited about the AI-ECG and Focused Cardiac Ultrasound trial because these techniques could revolutionize how we detect heart disease. Traditional heart disease diagnostics often rely on standard ECGs and comprehensive ultrasounds, which can be time-consuming and require specialized settings. However, the AI-ECG uses artificial intelligence to enhance the interpretation of ECG signals, potentially making it faster and more accurate. Meanwhile, Focused Cardiac Ultrasound offers a quicker and more portable way to assess heart health. This trial aims to find out if combining these innovative methods can lead to earlier and more accurate diagnoses, especially in diverse groups like pregnant women, adolescents, and community-dwelling adults.
What evidence suggests that this trial's treatments could be effective for cardiac disease?
Research has shown that AI-enhanced 12-lead ECGs, one of the methods tested in this trial, can effectively predict heart-related issues. They have an 86% success rate in identifying heart disease, meaning they correctly detect the condition most of the time. These AI models also predict the risk of heart failure with accuracy similar to traditional methods.
The 6-lead AI-ECG, another method under study in this trial, accurately detects left ventricular systolic dysfunction (LVSD), where the heart's left ventricle doesn't pump well. Studies have shown this method is as accurate as the 12-lead version.
Finally, AI-assisted focused cardiac ultrasound (FoCUS), also evaluated in this trial, has over 94% accuracy in spotting heart issues. It is especially useful for identifying structural heart disease and other heart problems early.26789Who Is on the Research Team?
Paul Friedman, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for young individuals aged 15-29 who are enrolled in a high school or college, or residents of Minnesota. They must provide informed consent (and assent if under age) to participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
AI-ECG and FoCUS Screening
Participants undergo AI-enabled electrocardiography and focused cardiac ultrasound to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds for cardiac disease
Follow-up
Participants are monitored for safety and effectiveness after screening
What Are the Treatments Tested in This Trial?
Interventions
- 12-Lead AI-ECG
- 6-Lead AI-ECG
- Focused Cardiac Ultrasound
Trial Overview
The study tests the use of AI-enhanced electrocardiography (ECG) and focused cardiac ultrasound to screen for heart disease in community populations. It aims to assess their effectiveness and accuracy.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Artificial intelligence-enhanced 12-lead electrocardiography ...
Artificial intelligence-estimated biological heart age using a 12-lead electrocardiogram predicts mortality and cardiovascular outcomes.
Predicting Heart Failure From 12-Lead ECGs Using AI
ECG-AI models based on information extracted from both 12-lead and single-lead ECGs have also been shown to predict the risk of HF with accuracy similar to ...
3.
newsroom.heart.org
newsroom.heart.org/news/an-ai-tool-detected-structural-heart-disease-in-adults-using-a-smartwatchAn AI tool detected structural heart disease in adults using ...
The AI algorithm accurately identified most people with heart disease (86% sensitivity) and was highly accurate in ruling out heart disease (99% ...
Artificial intelligence analysis of the single-lead ECG predicts ...
Artificial intelligence (AI) applied to a single-lead electrocardiogram (AI-ECG) can detect impaired left ventricular systolic dysfunction [ ...
Cardiovascular events and artificial intelligence-predicted ...
AI-predicted age using 12-lead ECGs showed superiority in predicting cardiovascular events compared with CA in younger patients, but not in older patients.
Artificial intelligence-estimated biological heart age using a ...
We developed a deep learning-based algorithm to estimate the AI ECG-heart age using standard 12-lead ECGs and evaluated whether it predicted mortality and ...
Diagnosis of cardiac conditions from 12-lead ...
The 12-lead electrocardiogram (ECG) remains a cornerstone of cardiovascular diagnosis, providing critical insights into cardiac rhythms, ...
Study Shows Promising Results for ECG Technology | DAIC
HeartBeam has reported promising results from its pivotal VALID-ECG study (https://ibn.fm/BDiIa), demonstrating that its synthesized 12-lead ECG ...
Prospective Evaluation of AI-ECG for SHD Detection
This study aims to improve the early detection of undiagnosed heart disease, which causes serious health issues, hospital admissions, and high healthcare costs ...
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