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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Argentina
    • 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
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Western Health
  • Canada
    • 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
  • Chile
      • Santiago, Chile, 7650567
        • Clínica Alemana de Santiago
  • France
      • Paris, France
        • Hôpital Bichat
      • Versailles, France
        • Versailles Hospital
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Erlangen, Germany, 91054
        • Neurologische Universitätsklinik Erlangen
      • Hamburg, Germany
        • Asklepios Klinik Nord, Department of Neurology
  • Mexico
      • Mexico City, Mexico, 14269
        • National Institute of Neurology and Neurosurgery
  • Poland
      • 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
  • South Africa
      • Bellville, South Africa, 7550
        • Tiervlei Trial Centre
  • Spain
      • 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
  • Switzerland
      • Bern, Switzerland, 3010
        • Stroke Center Inselspital University Hospital Bern
  • United Kingdom
      • 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
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Young ESUS

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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