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 range50 Years
SexALL
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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
✕. Any injury, eczema, dermatitis, chromatosis, or abnormality at the skin site where devices are applied
. 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.
✕. Patients with following condition or diseases: