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CompletedNCT03185520Y-ESUSUpdated Feb 4, 2021

Young ESUS Patient Registry

An observational study in Embolic Stroke of Undetermined Source, sponsored by Population Health Research Institute. Completed at 44 sites in 13 countries. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-02-04.

Sponsored by Population Health Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
535
Ages
21 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Embolic Stroke of Undetermined Source

Keywords

  • Stroke
  • Ischemic Stroke
  • Cryptogenic Stroke
  • Embolic stroke of undetermined source
  • ESUS
  • Cerebrovascular Disease
03

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients presenting to hospital-based stroke unit with an ESUS Stroke

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

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
535 participants (actual)
Target follow-up
18 Months
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort

    Time frame: Approximately 18 Months

Secondary outcomes

  1. Recurrent ischemic stroke in a well-defined Young ESUS cohort

    Time frame: Approximately 18 Months

  2. Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort

    Time frame: Baseline

06

Study locations

44 sites
  • Stanford University
    Stanford, California 94305-5778, United States
  • Presence Saint Joseph Medical Center
    Joliet, Illinois 60435, United States
  • Guilford Neurologic Associates
    Greensboro, North Carolina 27405, United States
  • Oregon Health and Science University
    Portland, Oregon 97239-3011, United States
  • University of South Carolina - School of Medicine - Neurology
    Columbia, South Carolina 29203, United States
  • Texas Tech University Health Sciences Center El Paso
    El Paso, Texas 79905, United States
  • University of Texas Health Center - San Antonio
    San Antonio, Texas 78229, United States
  • Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia
    Buenos Aires, Buenos Aires Province 1428, Argentina
  • Complejo Médico de la PFA Churruca Visca
    Buenos Aires, Buenos Aires Province C1437JCP, Argentina
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Western Health
    Footscray, Victoria 3011, Australia
  • University of Calgary/Foothills Medical Center
    Calgary, Alberta T2N2T9, Canada
  • Vancouver Stroke Program - Research Offices at Vancouver General Hospital
    Vancouver, British Columbia V5Z 1M9, Canada
  • Hamilton Health Sciences
    Hamilton, Ontario L8L 2X2, Canada
  • London Health Sciences Centre
    London, Ontario N6A 5A5, Canada
  • The Ottawa Hospital (Civic Campus)
    Ottawa, Ontario K1Y 4E9, Canada
  • University Health Network
    Toronto, Ontario M5T 2S8, Canada
  • Clínica Alemana de Santiago
    Santiago, 7650567, Chile
  • Hopital Bichat
    Paris, France
  • Versailles Hospital
    Versailles, France
  • Charité - Universitätsmedizin Berlin
    Berlin, 10117, Germany
  • Neurologische UNiversitätsklinik Erlangen
    Erlangen, 91054, Germany
  • Asklepios Klinik Nord, Department of Neurology
    Hamburg, Germany
  • National Institute of Neurology and Neurosurgery
    Mexico City, 14269, Mexico
  • Szpital Specjalistyczny im. Sw. Lukasza, Oddzial Neurologii z Oddzialem Udarowym
    Końskie, Swietokrzyskie 26-200, Poland
  • Institute Psychiatry and Neurology, 2 Department of Neurology
    Warsaw, 02-957, Poland
  • Tiervlei Trial Centre
    Bellville, 7550, South Africa
  • Hospital Universitari Germans Trias i Pujol
    Badalona, Barcelona 8916, Spain
  • Hospital de La Santa Creu Isant Pau
    Barcelona, 8041, Spain
  • Hospital Clínico Universitario
    Valladolid, 47003, Spain
  • Stroke Center Inselspital University Hospital Bern
    Bern, 3010, Switzerland
  • Buckinghamshire Healthcare NHS Trust
    High Wycombe, Buckinghamshire HP11 2TT, United Kingdom
  • Royal Devon & Exeter Hospital
    Exeter, Devon EX2 5DW, United Kingdom
  • West Hertfordshire Hospitals NHS Trust
    Watford, Hertfordshire WD18 0HB, United Kingdom
  • East Kent Hospitals - Queen Elizabeth the Queen Mother Hospital
    Margate, Kent CT9 4AN, United Kingdom
  • Northwick Park Hospital
    Harrow, Middlesex HA1 3UJ, United Kingdom
  • Yoevil District Hospital Foundation Trust
    Yeovil, Somerset BA21 4AT, United Kingdom
  • Cambridge University Foundation Trust Hospitals, Addenbrookes site
    Cambridge, CB2 OQQ, United Kingdom
  • Gloucestershire Royal Hospital
    Gloucester, GL1 3NN, United Kingdom
  • Imperial College Healthcare NHS Trust
    London, W6 8RF, United Kingdom
  • Royal Hallamshire Hospital
    Sheffield, S10 2Jf, 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, ST4 6QG, United Kingdom
  • Royal Wolverhampton Hospitals NHS trust
    Wolverhampton, WV10 0QP, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03185520
Lead sponsor
Population Health Research Institute
Responsible party
Sponsor
First posted
Jun 14, 2017
Start date
Feb 15, 2017
Primary completion
Dec 17, 2020
Completion
Dec 17, 2020
Last update
Feb 4, 2021

Study contacts

Kanjana S Perera, MD, FRCPC
principal investigator · McMaster University, Hamilton Health Sciences, and Population Health Research Institute
Robert G Hart, MD
principal investigator · McMaster University and Population Health Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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