Young ESUS Patient Registry

Completed

• Conditions: Embolic Stroke of Undetermined Source

• Registration Number: NCT03185520
• Lead Sponsor: Population Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-14
• Primary Completion: 2020-12-17
• Study Completion: 2020-12-17
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort	Approximately 18 Months

Secondary Outcome Measures

Name	Time	Method
Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort	Baseline
Recurrent ischemic stroke in a well-defined Young ESUS cohort	Approximately 18 Months

Trial Locations

Locations (44)

Stanford University; 🇺🇸 Stanford, California, United States

Presence Saint Joseph Medical Center; 🇺🇸 Joliet, Illinois, United States

Guilford Neurologic Associates; 🇺🇸 Greensboro, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of South Carolina - School of Medicine - Neurology; 🇺🇸 Columbia, South Carolina, United States

Texas Tech University Health Sciences Center El Paso; 🇺🇸 El Paso, Texas, United States

University of Texas Health Center - San Antonio; 🇺🇸 San Antonio, Texas, United States

Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia; 🇦🇷 Buenos Aires, Buenos Aires Province, Argentina

Complejo Médico de la PFA Churruca Visca; 🇦🇷 Buenos Aires, Buenos Aires Province, Argentina

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

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