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Young ESUS Patient Registry (Y-ESUS)

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ClinicalTrials.gov Identifier: NCT03185520
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
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.

Condition or disease
Embolic Stroke of Undetermined Source

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort [ Time Frame: Approximately 18 Months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to hospital-based stroke unit with an ESUS Stroke
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185520


Contacts
Contact: Dr. Kanjana S Perera & Dr. Robert Hart 9055274322 young.esus@phri.ca

Locations
United States, Texas
University of Texas Health Center - San Antonio Recruiting
San Antonio, Texas, United States, 78229
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Bayer
Investigators
Principal Investigator: Kanjana S Perera, MD, FRCPC McMaster University, Hamilton Health Sciences, and Population Health Research Institute
Principal Investigator: Robert G Hart, MD McMaster University and Population Health Research Institute

Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03185520     History of Changes
Other Study ID Numbers: Young ESUS
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Population Health Research Institute:
Stroke
Ischemic Stroke
Cryptogenic Stroke
Embolic stroke of undetermined source
ESUS
Cerebrovascular Disease

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases