Young ESUS Patient Registry (NCT03185520) | Clinical Trial Compass
CompletedNot Applicable
Young ESUS Patient Registry
United States, Argentina, Australia535 participantsStarted 2017-02-15
Plain-language summary
This study seeks to determine the clinical characteristics of young ESUS patients using diagnostic criteria of the Cryptogenic Stroke / ESUS International Working Group, and to determine the rates of stroke recurrence, death, and hospital readmission in a contemporary cohort of young ESUS patients during follow-up of up to 18 months.
Who can participate
Age range
21 Years – 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
. Embolic stroke of undetermined source (ESUS) within 60 days, defined as:
. Recent ESUS (including transient ischemic attack with positive neuroimaging) visualized by brain computed tomography (CT) or magnetic resonance imaging (MRI) that is not lacunar (i.e., lacunar infarcts are subcortical infarcts ≤ 1.5 cm in the territory of middle cerebral artery or pons; infarcts involving the cerebellum or lateral medulla are not considered as lacunar infarcts). Patients with multiple simultaneous acute lacunar infarcts on diffusion weighted imaging may be included. In case of embolic large artery occlusions clearly documented on angiography who undergo successful recanalization, visualization of infarct on neuroimaging is not mandated, and
. Absence of cervical carotid atherosclerotic stenosis (or vertebral and basilar atherosclerotic stenosis in case of posterior circulation stroke), that is \>50%, or occlusion in arteries supplying the area of ischemia, (unless deemed embolic) in CT or magnetic resonance (MR) angiography or conventional angiography or ultrasound, and
. No history of atrial fibrillation (AF), no documented AF on 12-lead electrocardiogram or episode of AF lasting 6 minutes or longer detected after ≥ 24-hour cardiac rhythm monitoring (Holter or telemetry; at least 20 hours acceptable), and
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
Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort
. No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
. No other specific cause of stroke identified by routine clinical care (e.g., arteritis, dissection, migraine/vasospasm, drug abuse)
. Age ≥ 21 to ≤ 50 years
. Written informed consent with local regulations governing research in human subjects
Exclusion criteria
. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)
. Enrollment in an investigational study on ESUS
. If imaging of intracranial arteries are performed by CT or MR angiography, digital subtraction angiography or transcranial Doppler: \>50% luminal stenosis or occlusion in arteries supplying the area of ischemia (unless deemed embolic)