Young ESUS Patient Registry (Y-ESUS)

February 3, 2021 updated by: Population Health Research Institute

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

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort
Time Frame: Approximately 18 Months
Approximately 18 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrent ischemic stroke in a well-defined Young ESUS cohort
Time Frame: Approximately 18 Months
Approximately 18 Months
Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kanjana S Perera, MD, FRCPC, McMaster University, Hamilton Health Sciences, and Population Health Research Institute
  • Principal Investigator: Robert G Hart, MD, McMaster University and Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

December 17, 2020

Study Completion (Actual)

December 17, 2020

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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