Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF (NCT04208971) | Clinical Trial Compass
CompletedNot Applicable
Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF
United States1,225 participantsStarted 2020-11-02
Plain-language summary
This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.
Who can participate
Age range
18 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:
* Age ≥18 years
* Had a 10-second 12-lead ECG done at Mayo Clinic
* Men with CHA2DS2-VASc ≥2 or women with CHA2DS2-VASc ≥3
Exclusion Criteria:
* Diagnosed atrial fibrillation or atrial flutter
* Missing date of birth or sex in the electronic health record (EHR)
* A history of intracranial bleeding
* A history of end-stage kidney disease
* Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
* Deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.
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
Diagnosis of Atrial Fibrillation as Detected by Patch Application