Real-World Evaluation of Eko Algorithms in a Point of Care Setting (NCT05459545) | Clinical Trial Compass
CompletedNot Applicable
Real-World Evaluation of Eko Algorithms in a Point of Care Setting
United States371 participantsStarted 2022-04-15
Plain-language summary
The purpose of this research is to prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient consents to participation
* Willing to have heart sounds recorded with an electronic stethoscope
* Willing to undergo echocardiography
* Willing to undergo a 12-lead electrocardiogram
* Adults aged 65 years and older
* History of at least one of the following: hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography
* No prior diagnosis of valve disease or heart murmur
Exclusion Criteria:
* Patient is unwilling or unable to give written informed consent
* Patients experiencing a known or suspected acute cardiac event
* Under the age of 65 years old
* Prior diagnosis of valve disease or heart murmurs
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity and Specificity of Eko's AI relative to ground truth
Timeframe: 02/20/2022 - 05/20/2024
2
Sensitivity and Specificity of Eko's AI relative to PCP auscultation and ground truth
Timeframe: 02/20/2022 - 05/20/2024
3
Positive and negative predictive values for AI detecting new VHD
Timeframe: 02/20/2022 - 05/20/2024
4
Positive and negative predictive values for PCP detecting new VHD