Clinical trial NCT03185520: Young ESUS Patient Registry
Official title: Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Embolic Stroke of Undetermined Source
Keywords: Stroke
Ischemic Stroke
Cryptogenic Stroke
Embolic stroke of undetermined source
ESUS
Cerebrovascular Disease
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 535
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to hospital-based stroke unit with an ESUS Stroke

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort
timeFrame: Approximately 18 Months
Secondary outcomes:
measure: Recurrent ischemic stroke in a well-defined Young ESUS cohort
timeFrame: Approximately 18 Months
measure: Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort
timeFrame: Baseline
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Joliet
country: United States
facility: Presence Saint Joseph Medical Center
state: Illinois
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Columbia
country: United States
facility: University of South Carolina - School of Medicine - Neurology
state: South Carolina
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center El Paso
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Center - San Antonio
state: Texas
city: Buenos Aires
country: Argentina
facility: Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia
state: Buenos Aires Province
city: Buenos Aires
country: Argentina
facility: Complejo Médico de la PFA Churruca Visca
state: Buenos Aires Province
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Footscray
country: Australia
facility: Western Health
state: Victoria
city: Calgary
country: Canada
facility: University of Calgary/Foothills Medical Center
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Stroke Program - Research Offices at Vancouver General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital (Civic Campus)
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Santiago
country: Chile
facility: Clínica Alemana de Santiago
city: Paris
country: France
facility: Hopital Bichat
city: Versailles
country: France
facility: Versailles Hospital
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Erlangen
country: Germany
facility: Neurologische UNiversitätsklinik Erlangen
city: Hamburg
country: Germany
facility: Asklepios Klinik Nord, Department of Neurology
city: Mexico City
country: Mexico
facility: National Institute of Neurology and Neurosurgery
city: Końskie
country: Poland
facility: Szpital Specjalistyczny im. Sw. Lukasza, Oddzial Neurologii z Oddzialem Udarowym
state: Swietokrzyskie
city: Warsaw
country: Poland
facility: Institute Psychiatry and Neurology, 2 Department of Neurology
city: Bellville
country: South Africa
facility: Tiervlei Trial Centre
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu Isant Pau
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario
city: Bern
country: Switzerland
facility: Stroke Center Inselspital University Hospital Bern
city: High Wycombe
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
state: Buckinghamshire
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
state: Devon
city: Watford
country: United Kingdom
facility: West Hertfordshire Hospitals NHS Trust
state: Hertfordshire
city: Margate
country: United Kingdom
facility: East Kent Hospitals - Queen Elizabeth the Queen Mother Hospital
state: Kent
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
city: Yeovil
country: United Kingdom
facility: Yoevil District Hospital Foundation Trust
state: Somerset
city: Cambridge
country: United Kingdom
facility: Cambridge University Foundation Trust Hospitals, Addenbrookes site
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Southend-on-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton Hospitals NHS trust
Study officials:
affiliation: McMaster University, Hamilton Health Sciences, and Population Health Research Institute
name: Kanjana S Perera, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University and Population Health Research Institute
name: Robert G Hart, MD
role: PRINCIPAL_INVESTIGATOR
References: