Embolic Stroke of Undetermined SourceY-ESUSNCT03185520
Young ESUS Patient Registry
An observational study of Embolic Stroke of Undetermined Source, run by Population Health Research Institute at 44 sites in 13 countries.
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… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- How many people
- 535 participants
- Where
- 44 sitesin 13 countries
- Study dates
- 15 Feb 2017to 17 Dec 2020
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients presenting to hospital-based stroke unit with an ESUS Stroke
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
44 sites in 13 countries.
44 sites in 13 countries
United Kingdom13 sites
Cambridge University Foundation Trust Hospitals, Addenbrookes site
Cambridge, CB2 OQQ
Royal Devon & Exeter Hospital
Exeter, Devon, EX2 5DW
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
Northwick Park Hospital
Harrow, Middlesex, HA1 3UJ
Buckinghamshire Healthcare NHS Trust
High Wycombe, Buckinghamshire, HP11 2TT
Imperial College Healthcare NHS Trust
London, W6 8RF
East Kent Hospitals - Queen Elizabeth the Queen Mother Hospital
Margate, Kent, CT9 4AN
Royal Hallamshire Hospital
Sheffield, S10 2Jf
Southend University Hospital NHS Foundation Trust
Southend-on-Sea
Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG
West Hertfordshire Hospitals NHS Trust
Watford, Hertfordshire, WD18 0HB
Royal Wolverhampton Hospitals NHS trust
Wolverhampton, WV10 0QP
Yoevil District Hospital Foundation Trust
Yeovil, Somerset, BA21 4AT
United States7 sites
University of South Carolina - School of Medicine - Neurology
Columbia, South Carolina, 29203
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
Guilford Neurologic Associates
Greensboro, North Carolina, 27405
Presence Saint Joseph Medical Center
Joliet, Illinois, 60435
Oregon Health and Science University
Portland, Oregon, 97239-3011
University of Texas Health Center - San Antonio
San Antonio, Texas, 78229
Stanford University
Stanford, California, 94305-5778
Canada6 sites
University of Calgary/Foothills Medical Center
Calgary, Alberta, T2N2T9
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
London Health Sciences Centre
London, Ontario, N6A 5A5
The Ottawa Hospital (Civic Campus)
Ottawa, Ontario, K1Y 4E9
University Health Network
Toronto, Ontario, M5T 2S8
Vancouver Stroke Program - Research Offices at Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Germany3 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Neurologische UNiversitätsklinik Erlangen
Erlangen, 91054
Asklepios Klinik Nord, Department of Neurology
Hamburg
Spain3 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 8916
Hospital de La Santa Creu Isant Pau
Barcelona, 8041
Hospital Clínico Universitario
Valladolid, 47003
Argentina2 sites
Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia
Buenos Aires, Buenos Aires, 1428
Complejo Médico de la PFA Churruca Visca
Buenos Aires, Buenos Aires, C1437JCP
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Western Health
Footscray, Victoria, 3011
Poland2 sites
Szpital Specjalistyczny im. Sw. Lukasza, Oddzial Neurologii z Oddzialem Udarowym
Gmina Końskie, Świętokrzyskie Voivodeship, 26-200
Institute Psychiatry and Neurology, 2 Department of Neurology
Warsaw, 02-957
Mexico1 site
National Institute of Neurology and Neurosurgery
Mexico City, 14269
Switzerland1 site
Stroke Center Inselspital University Hospital Bern
Bern, 3010
About this study
Official title: 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.
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- Stroke, Ischemic Stroke, Cryptogenic Stroke, Embolic stroke of undetermined source, ESUS, Cerebrovascular Disease
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebrovascular Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort
Measured: Approximately 18 Months
Secondary outcomes (2)
Recurrent ischemic stroke in a well-defined Young ESUS cohort
Measured: Approximately 18 Months
Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Feb 2017
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 535 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanjana S Perera, MD, FRCPC, Principal investigator, McMaster University, Hamilton Health Sciences, and Population Health Research InstituteRobert G Hart, MD, Principal investigator, McMaster University and Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185520
- Sponsor's protocol ID
- Young ESUS
- Acronym
- Y-ESUS
- Status last verified
- Feb 2021
- First submitted
- 9 Jun 2017
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meinel TR, Tsiplova K, Taylor A, Meseguer E, Haeusler KG, Hart RG, Arnold M, Perera KS. Chronic ischemic lesions and presence of patent foramen ovale in young adults with embolic stroke of undetermined source: Results of the young ESUS patient registry. Int J Stroke. 2024 Apr;19(4):470-477. doi: 10.1177/17474930231217917. Epub 2023 Dec 11.
PubMed 37981572
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)
- ClinicalTrials.gov ID
- NCT03185520
- Acronym / sponsor ID
- Y-ESUS / Young ESUS
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- Stroke, Ischemic Stroke, Cryptogenic Stroke, Embolic stroke of undetermined source, ESUS, Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients presenting to hospital-based stroke unit with an ESUS Stroke
Key inclusion criteria (8 listed)
- Embolic stroke of undetermined source (ESUS) within 60 days, defined as:
- Age ≥ 21 to ≤ 50 years
- Written informed consent with local regulations governing research in human subjects
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort
Time frame: Approximately 18 Months
2 secondary outcomes
Recurrent ischemic stroke in a well-defined Young ESUS cohort
Time frame: Approximately 18 Months
Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 37981572Meinel TR, Tsiplova K, Taylor A, Meseguer E, Haeusler KG, Hart RG, Arnold M, Perera KS. Chronic ischemic lesions and presence of patent foramen ovale in young adults with embolic stroke of undetermined source: Results of the young ESUS patient registry. Int J Stroke. 2024 Apr;19(4):470-477. doi: 10.1177/17474930231217917. Epub 2023 Dec 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
44 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embolic Stroke of Undetermined Source, run by Population Health Research Institute at 44 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United Kingdom, United States, Canada, Germany, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort (time frame: Approximately 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.