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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03185520




Registration number
NCT03185520
Ethics application status
Date submitted
9/06/2017
Date registered
14/06/2017
Date last updated
4/02/2021

Titles & IDs
Public title
Young ESUS Patient Registry
Scientific title
Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)
Secondary ID [1] 0 0
Young ESUS
Universal Trial Number (UTN)
Trial acronym
Y-ESUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Embolic Stroke of Undetermined Source 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort
Timepoint [1] 0 0
Approximately 18 Months
Secondary outcome [1] 0 0
Recurrent ischemic stroke in a well-defined Young ESUS cohort
Timepoint [1] 0 0
Approximately 18 Months
Secondary outcome [2] 0 0
Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort
Timepoint [2] 0 0
Baseline

Eligibility
Key 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
Minimum age
21 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/12/2020
Sample size
Target
Accrual to date
Final
535
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Western Health - Footscray
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires Province
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Versailles
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Erlangen
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Mexico
State/province [17] 0 0
Mexico City
Country [18] 0 0
Poland
State/province [18] 0 0
Swietokrzyskie
Country [19] 0 0
Poland
State/province [19] 0 0
Warsaw
Country [20] 0 0
South Africa
State/province [20] 0 0
Bellville
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Valladolid
Country [23] 0 0
Switzerland
State/province [23] 0 0
Bern
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Buckinghamshire
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Devon
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Hertfordshire
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Kent
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Middlesex
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Somerset
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Cambridge
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Gloucester
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Sheffield
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Southend-on-Sea
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Stoke-on-Trent
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03185520
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kanjana S Perera, MD, FRCPC
Address 0 0
McMaster University, Hamilton Health Sciences, and Population Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03185520