An Open-label Study of EZYPRO® in Atrial Fibrillation Detection on ESUS Patients (NCT05089435) | Clinical Trial Compass
UnknownPhase 4
An Open-label Study of EZYPRO® in Atrial Fibrillation Detection on ESUS Patients
Taiwan500 participantsStarted 2022-03-28
Plain-language summary
The aim of the study is to evaluate the effectiveness and safety of the 14-day continuous ECG patch monitor (EZYPRO®) compared with a 24-hour Holter monitor in the detection of atrial fibrillation (AF) among ESUS patients.
Who can participate
Age range
50 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
. Patients are male or female, aged ≥ 50 years.
. Patients must be able to understand and sign the informed consent documents within 10 days of ischemic stroke diagnosis and aware of the investigational nature of the study.
. Patients must be willing to comply with protocol stated requirements, instructions, and restrictions during the study.
. Patients who have stable vital signs for at least 24 hours, defined as normal respiration, afebrile, and systolic blood pressure ≤ 220 mmHg.
. Patients who are diagnosed with acute ischemic stroke and undergo a diagnostic workup using brain magnetic resonance imaging (MRI), brain magnetic resonance angiography (MRA), 12-lead ECG, carotid duplex ultrasound, with or without transcranial color-coded duplex sonography (TCCS), and cardiac echo (transthoracic echocardiography \[TTE\]) to meet the concept of "nearly embolic stroke of undetermined source (ESUS)" as defined by the following criteria:
Exclusion criteria
. Patients with the following skin related issues that could put patients at risk, interfere with study evaluations, or prevent meeting the requirements of the study:
. Intolerable, severe skin allergies to the 24-hour Holter monitor or 14-day EZYPRO® or history of severe skin allergies to medical adhesive bandages
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.
. Any injury, eczema, dermatitis, chromatosis, or abnormality at the skin site where devices are applied
. Hyperhidrosis
. Patients who have contraindication to either of the antiplatelet agents which might be used in this study (i.e. aspirin and/or clopidogrel) or to all types of non-vitamin K antagonist oral anticoagulant (NOAC) (due to allergy, mechanical valve replacement, renal insufficient with creatinine clearance \[CCr\] \< 15 ml/min, moderate to severe mitral stenosis, etc.).
. Patients who are evaluated as Modified Rankin Scale \> 4.
. Mental/physical/social condition (including dementia) which could preclude performing efficacy or safety assessments.