Young ESUS Patient Registry

Embolic Stroke of Undetermined Source Clinical Trial

— Y-ESUS  

Official title:

Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185520
• Other study ID #: Young ESUS
• Status: Completed
• Start date: February 15, 2017
• Est. completion date: December 17, 2020

Study information

• Verified date: February 2021
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: December 17, 2020
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Embolic stroke of undetermined source (ESUS) within 60 days, defined as:

1. 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

2. 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

3. 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

4. No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and

5. No other specific cause of stroke identified by routine clinical care (e.g., arteritis, dissection, migraine/vasospasm, drug abuse)

2. Age = 21 to = 50 years

3. Written informed consent with local regulations governing research in human subjects

Exclusion Criteria:

1. 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)

2. Enrollment in an investigational study on ESUS

3. 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)

Related Conditions & MeSH terms

• Embolic Stroke of Undetermined Source
• Stroke

Locations

Country	Name	City	State
Argentina	Complejo Médico de la PFA Churruca Visca	Buenos Aires	Buenos Aires Province
Argentina	Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia	Buenos Aires	Buenos Aires Province
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Western Health	Footscray	Victoria
Canada	University of Calgary/Foothills Medical Center	Calgary	Alberta
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	Vancouver Stroke Program - Research Offices at Vancouver General Hospital	Vancouver	British Columbia
Chile	Clínica Alemana de Santiago	Santiago
France	Hopital Bichat	Paris
France	Versailles Hospital	Versailles
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Neurologische UNiversitätsklinik Erlangen	Erlangen
Germany	Asklepios Klinik Nord, Department of Neurology	Hamburg
Mexico	National Institute of Neurology and Neurosurgery	Mexico City
Poland	Szpital Specjalistyczny im. Sw. Lukasza, Oddzial Neurologii z Oddzialem Udarowym	Konskie	Swietokrzyskie
Poland	Institute Psychiatry and Neurology, 2 Department of Neurology	Warsaw
South Africa	Tiervlei Trial Centre	Bellville
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de La Santa Creu Isant Pau	Barcelona
Spain	Hospital Clínico Universitario	Valladolid
Switzerland	Stroke Center Inselspital University Hospital Bern	Bern
United Kingdom	Cambridge University Foundation Trust Hospitals, Addenbrookes site	Cambridge
United Kingdom	Royal Devon & Exeter Hospital	Exeter	Devon
United Kingdom	Gloucestershire Royal Hospital	Gloucester
United Kingdom	Northwick Park Hospital	Harrow	Middlesex
United Kingdom	Buckinghamshire Healthcare NHS Trust	High Wycombe	Buckinghamshire
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	East Kent Hospitals - Queen Elizabeth the Queen Mother Hospital	Margate	Kent
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	Southend University Hospital NHS Foundation Trust	Southend-on-Sea
United Kingdom	Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust	Stoke-on-Trent
United Kingdom	West Hertfordshire Hospitals NHS Trust	Watford	Hertfordshire
United Kingdom	Royal Wolverhampton Hospitals NHS trust	Wolverhampton
United Kingdom	Yoevil District Hospital Foundation Trust	Yeovil	Somerset
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	Guilford Neurologic Associates	Greensboro	North Carolina
United States	Presence Saint Joseph Medical Center	Joliet	Illinois
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Texas Health Center - San Antonio	San Antonio	Texas
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  France,  Germany,  Mexico,  Poland,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort		Approximately 18 Months
Secondary	Recurrent ischemic stroke in a well-defined Young ESUS cohort		Approximately 18 Months
Secondary	Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort		Baseline