Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT03185520
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2017-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Young ESUS Patient Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 535}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent ischemic stroke and/or death in a well-defined Young ESUS cohort', 'timeFrame': 'Approximately 18 Months'}], 'secondaryOutcomes': [{'measure': 'Recurrent ischemic stroke in a well-defined Young ESUS cohort', 'timeFrame': 'Approximately 18 Months'}, {'measure': 'Prevalence of Patent Foramen Ovale in a well-defined Young ESUS cohort', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Ischemic Stroke', 'Cryptogenic Stroke', 'Embolic stroke of undetermined source', 'ESUS', 'Cerebrovascular Disease'], 'conditions': ['Embolic Stroke of Undetermined Source']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to hospital-based stroke unit with an ESUS Stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Embolic stroke of undetermined source (ESUS) within 60 days, defined as:\n\n 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\n 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\n 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\n 4. No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and\n 5. No other specific cause of stroke identified by routine clinical care (e.g., arteritis, dissection, migraine/vasospasm, drug abuse)\n2. Age ≥ 21 to ≤ 50 years\n3. Written informed consent with local regulations governing research in human subjects\n\nExclusion Criteria:\n\n1. 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)\n2. Enrollment in an investigational study on ESUS\n3. 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)'}, 'identificationModule': {'nctId': 'NCT03185520', 'acronym': 'Y-ESUS', 'briefTitle': 'Young ESUS Patient Registry', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)', 'orgStudyIdInfo': {'id': 'Young ESUS'}}, 'contactsLocationsModule': {'locations': [{'zip': '94305-5778', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Presence Saint Joseph Medical Center', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '27405', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Guilford Neurologic Associates', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '97239-3011', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina - School of Medicine - Neurology', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Center - San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '1428', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia'}, {'zip': 'C1437JCP', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Complejo Médico de la PFA Churruca Visca'}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3011', 'city': 'Footscray', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Western Health', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'zip': 'T2N2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary/Foothills Medical Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver Stroke Program - Research Offices at Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital (Civic Campus)', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '7650567', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Clínica Alemana de Santiago', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Versailles', 'country': 'France', 'facility': 'Versailles Hospital', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Neurologische UNiversitätsklinik Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik Nord, Department of Neurology', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '14269', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'National Institute of Neurology and Neurosurgery', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '02-957', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Institute Psychiatry and Neurology, 2 Department of Neurology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '26-200', 'city': 'Gmina Końskie', 'state': 'Świętokrzyskie Voivodeship', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny im. Sw. Lukasza, Oddzial Neurologii z Oddzialem Udarowym', 'geoPoint': {'lat': 51.19166, 'lon': 20.40607}}, {'zip': '7550', 'city': 'Bellville', 'country': 'South Africa', 'facility': 'Tiervlei Trial Centre', 'geoPoint': {'lat': -33.90022, 'lon': 18.62847}}, {'zip': '8916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '8041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de La Santa Creu Isant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Stroke Center Inselspital University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': 'HP11 2TT', 'city': 'High Wycombe', 'state': 'Buckinghamshire', 'country': 'United Kingdom', 'facility': 'Buckinghamshire Healthcare NHS Trust', 'geoPoint': {'lat': 51.62907, 'lon': -0.74934}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Royal Devon & Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'WD18 0HB', 'city': 'Watford', 'state': 'Hertfordshire', 'country': 'United Kingdom', 'facility': 'West Hertfordshire Hospitals NHS Trust', 'geoPoint': {'lat': 51.65531, 'lon': -0.39602}}, {'zip': 'CT9 4AN', 'city': 'Margate', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'East Kent Hospitals - Queen Elizabeth the Queen Mother Hospital', 'geoPoint': {'lat': 51.38132, 'lon': 1.38617}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Northwick Park Hospital', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'BA21 4AT', 'city': 'Yeovil', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': 'Yoevil District Hospital Foundation Trust', 'geoPoint': {'lat': 50.94159, 'lon': -2.63211}}, {'zip': 'CB2 OQQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Foundation Trust Hospitals, Addenbrookes site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'GL1 3NN', 'city': 'Gloucester', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'W6 8RF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'S10 2Jf', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Southend-on-Sea', 'country': 'United Kingdom', 'facility': 'Southend University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.53782, 'lon': 0.71433}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'Royal Wolverhampton Hospitals NHS trust', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Kanjana S Perera, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University, Hamilton Health Sciences, and Population Health Research Institute'}, {'name': 'Robert G Hart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University and Population Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}