A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening
{ "Study of AI-ECG and Focused Cardiac Ultrasound for Heart Disease Screening", "This study is looking at how well two diagnostic tools, AI-ECG (artificial intelligence-enabled electrocardiogram) and Focus Screening (focused cardiac ultrasonography), can find structural heart disease (SHD) in adults who don't currently have symptoms. You might be eligible if you are over 18, don't have a medical need for an echocardiogram, and haven't been diagnosed with certain heart conditions like heart failure or hypertrophic cardiomyopathy. The study aims to see what percentage of participants are diagnosed with SHD and how accurate these tests are over one year. The current recruitment status is unclear, and the study plans to enroll 2705 participants.", "design": "This is an observational study that plans to enroll 2705 adult participants. It evaluates the effectiveness of AI-ECG and Focus Screening for detecting heart disease.", "commitments": "Participants will undergo an AI-ECG at the start of the study. If the AI-ECG shows a positive result, you will then have a Focus Screening (focused cardiac ultrasound).", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for up to one year to measure diagnoses of structural heart disease and test accuracy.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Gal Tsaban, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percentage of subjects to be diagnosed with SHD (structural heart disease)Baseline, 6 months, 1 year
Percentage of subjects to be diagnosed with SHD will be determined by the number of subjects that have a positive SHD screening. Positive SHD screening is defined by any one of the following: decreased LVEF (left ventricular ejection fraction), cardiac amyloidosis, aortic stenosis, and hypertrophic cardiomyopathy.
- Positive predictive value (PPV)Baseline, 6 months, 1 year
Positive predictive value (PPV) will be measured as a percentage. PPV will reflect the percentage of times that each screening pathway matches a formal echocardiogram diagnosis.