Young ESUS Patient Registry

Completed

Conditions studied: Embolic Stroke of Undetermined Source

In brief

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.

Key facts

Study ID

NCT03185520

Run by

Population Health Research Institute

People needed

535

Starts

2017-02-15

Expected to finish

2020-12-17

Last updated by the study team

2021-02-04

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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)

Where it is running

• Stanford University — Stanford, California, United States
• Presence Saint Joseph Medical Center — Joliet, Illinois, United States
• Guilford Neurologic Associates — Greensboro, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of South Carolina - School of Medicine - Neurology — Columbia, South Carolina, United States
• Texas Tech University Health Sciences Center El Paso — El Paso, Texas, United States
• University of Texas Health Center - San Antonio — San Antonio, Texas, United States
• Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia — Buenos Aires, Buenos Aires, Argentina
• Complejo Médico de la PFA Churruca Visca — Buenos Aires, Buenos Aires, Argentina
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Western Health — Footscray, Victoria, Australia
• University of Calgary/Foothills Medical Center — Calgary, Alberta, Canada
• Vancouver Stroke Program - Research Offices at Vancouver General Hospital — Vancouver, British Columbia, Canada
• Hamilton Health Sciences — Hamilton, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• The Ottawa Hospital (Civic Campus) — Ottawa, Ontario, Canada
• University Health Network — Toronto, Ontario, Canada
• Clínica Alemana de Santiago — Santiago, Chile
• Hopital Bichat — Paris, France
• Versailles Hospital — Versailles, France
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Neurologische UNiversitätsklinik Erlangen — Erlangen, Germany
• Asklepios Klinik Nord, Department of Neurology — Hamburg, Germany
• National Institute of Neurology and Neurosurgery — Mexico City, Mexico
• Institute Psychiatry and Neurology, 2 Department of Neurology — Warsaw, Poland

Full record on ClinicalTrials.gov

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