Using AI and ultrasound to improve heart disease screening
Integrating Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening; Structural Cardiac Assessment With Networked AI-ECG & FOCUS (SCAN) Study
This study is testing if using AI with heart scans can help find serious heart problems in people who don’t have any symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06891222 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combined approach using artificial intelligence-enabled electrocardiograms (AI-ECG) and focused cardiac ultrasonography (FOCUS) for screening asymptomatic outpatients referred for an ECG. Participants will be enrolled electronically, and the study aims to enhance the detection of significant heart disease (SHD) in individuals who do not show symptoms. The methodology focuses on comparing the outcomes of this active screening approach against traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years of age who do not have a clinically indicated echocardiogram.
Not a fit: Patients with a prior history of significant heart disease or those who have had a recent echocardiogram may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of cardiac diseases in asymptomatic patients.
How similar studies have performed: Other studies have shown promise in using AI and ultrasound for cardiac screening, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>18 years of age) * Echocardiogram is not clinically indicated Exclusion Criteria: * Prior history of congenital or acquired SHD, as defined by the following 1. Aortic Stenosis: 2. Heart Failure 3. Left Ventricular Dysfunction 4. Cardiac Amyloidosis 5. Hypertrophic Cardiomyopathy (HCM) 6. Rheumatic Heart Disease 7. Congenital Heart Disease * Recent (within last 12 months) echocardiogram * Scheduled clinically indicated future echocardiogram * Inability to provide informed consent to participate in the study
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Gal Tsaban, M.D., Ph.D. — Mayo Clinic
- Study coordinator: Catalina Paraschiv, M.D., Ph.D.
- Email: Paraschiv.Catalina@mayo.edu
- Phone: 507-293-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.