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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03185520
Other study ID # Young ESUS
Secondary ID
Status Recruiting
Phase N/A
First received June 9, 2017
Last updated June 9, 2017
Start date February 15, 2017
Est. completion date December 2018

Study information

Verified date June 2017
Source Population Health Research Institute
Contact Dr. Kanjana S Perera & Dr. Robert Hart
Phone 9055274322
Email young.esus@phri.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 up to 18 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Hamilton Health Sciences Hamilton Ontario
United States University of Texas Health Center - San Antonio San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
Population Health Research Institute Bayer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort Approximately 18 Months
Secondary Recurrent ischemic stroke in a well-defined Young ESUS cohort Approximately 18 Months
Secondary Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort Baseline
See also
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Completed NCT03377465 - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis N/A
Enrolling by invitation NCT02766205 - Prediction of AF in ESUS N/A
Not yet recruiting NCT03329365 - Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS N/A