Young ESUS Patient Registry

NCT03185520 | Completed

• 1 other identifier: Young ESUS
• Study Type: observational
• Target: 535
• Locations: 13 countries
• Sites: 44

Brief 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.

Conditions

Embolic Stroke of Undetermined Source

Keywords

Stroke; Ischemic Stroke; Cryptogenic Stroke; Embolic stroke of undetermined source; ESUS; Cerebrovascular Disease

Outcome Measures

Primary Outcomes (1)

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

  Approximately 18 Months

Secondary Outcomes (2)

• Recurrent ischemic stroke in a well-defined Young ESUS cohort

  Approximately 18 Months

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

  Baseline

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (44)

Stanford University

Stanford, California, 94305-5778, United States

Location

Presence Saint Joseph Medical Center

Joliet, Illinois, 60435, United States

Location

Guilford Neurologic Associates

Greensboro, North Carolina, 27405, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3011, United States

Location

University of South Carolina - School of Medicine - Neurology

Columbia, South Carolina, 29203, United States

Location

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

University of Texas Health Center - San Antonio

San Antonio, Texas, 78229, United States

Location

Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia

Buenos Aires, Buenos Aires, 1428, Argentina

Location

Complejo Médico de la PFA Churruca Visca

Buenos Aires, Buenos Aires, C1437JCP, Argentina

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Western Health

Footscray, Victoria, 3011, Australia

Location

University of Calgary/Foothills Medical Center

Calgary, Alberta, T2N2T9, Canada

Location

Vancouver Stroke Program - Research Offices at Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

The Ottawa Hospital (Civic Campus)

Ottawa, Ontario, K1Y 4E9, Canada

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Clínica Alemana de Santiago

Santiago, 7650567, Chile

Location

Hopital Bichat

Paris, France

Location

Versailles Hospital

Versailles, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Neurologische UNiversitätsklinik Erlangen

Erlangen, 91054, Germany

Location

Asklepios Klinik Nord, Department of Neurology

Hamburg, Germany

Location

National Institute of Neurology and Neurosurgery

Mexico City, 14269, Mexico

Location

Institute Psychiatry and Neurology, 2 Department of Neurology

Warsaw, 02-957, Poland

Location

Szpital Specjalistyczny im. Sw. Lukasza, Oddzial Neurologii z Oddzialem Udarowym

Gmina Końskie, Świętokrzyskie Voivodeship, 26-200, Poland

Location

Tiervlei Trial Centre

Bellville, 7550, South Africa

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 8916, Spain

Location

Hospital de La Santa Creu Isant Pau

Barcelona, 8041, Spain

Location

Hospital Clínico Universitario

Valladolid, 47003, Spain

Location

Stroke Center Inselspital University Hospital Bern

Bern, 3010, Switzerland

Location

Buckinghamshire Healthcare NHS Trust

High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom

Location

Royal Devon & Exeter Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

West Hertfordshire Hospitals NHS Trust

Watford, Hertfordshire, WD18 0HB, United Kingdom

Location

East Kent Hospitals - Queen Elizabeth the Queen Mother Hospital

Margate, Kent, CT9 4AN, United Kingdom

Location

Northwick Park Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Yoevil District Hospital Foundation Trust

Yeovil, Somerset, BA21 4AT, United Kingdom

Location

Cambridge University Foundation Trust Hospitals, Addenbrookes site

Cambridge, CB2 OQQ, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, GL1 3NN, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2Jf, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Southend-on-Sea, United Kingdom

Location

Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Royal Wolverhampton Hospitals NHS trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: February 15, 2017
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); AR (2); AU (2); PL (2); DE (3); ZA (1); GB (13); US (7); ES (3); CH (1); CA (6); FR (2); ME (1)