Skip to main content
OpenTrials
Completed

NCT Number: NCT03185520

Young ESUS Patient Registry

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Médico de la PFA Churruca Visca, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

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

    Time frame: Approximately 18 Months

Secondary outcomes

  1. Recurrent ischemic stroke in a well-defined Young ESUS cohort

    Time frame: Approximately 18 Months

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

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)

Acronym: Y-ESUS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2017
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.