Shanghai Prospective Registry Study of Ischemic Stroke

Overview

This study aims to conduct a prospective cohort study on patients with imaging-confirmed ischemic stroke based on the 4S database. The primary objectives are to investigate the incidence, clinical characteristics, risk factors, and pathophysiological mechanisms of young-onset stroke, as well as to analyze the evolving trends in the etiology of young-onset stroke in the Shanghai region over recent years. This includes examining the roles of traditional risk factors (such as hypertension and diabetes) and emerging factors (such as air pollution and lifestyle changes), and exploring the associations between these factors and patient outcomes. Additionally, the study will analyze the association between reperfusion therapies such as intravenous thrombolysis, acute-phase management, and secondary prevention with clinical outcomes. Finally, it will delve into the screening, treatment, and challenges associated with genetic young stroke patients with Farby syndrome, providing comprehensive information for regional stroke prevention and control strategies targeting young stroke patients.

Detailed description

This study is designed as a prospective cohort investigation utilizing data from the 4S database, focusing specifically on patients with imaging-confirmed ischemic stroke who are classified as having young-onset stroke (typically defined as occurring in individuals under 55 years of age). The purpose is to provide a thorough understanding of stroke in younger populations within the Shanghai region through collecting relevant clinical information of patients.

Primary outcome measures

• Patient general information [Time frame: Upon admission]
• Risk factors (assessed by medical history review and clinical evaluation) [Time frame: Upon admission]
• Pre-illness medication history（assessed by medical history review） [Time frame: Upon admission]
• Baseline National Institutes of Health Stroke Scale (NIHSS) Score [Time frame: Upon admission]
• Pre-Stroke Modified Rankin Scale (mRS) Score [Time frame: Prior to stroke admission (assessed upon current admission)]
• Time Metrics from Symptom Onset to Hospital Presentation [Time frame: Upon admission]
• Number of Participants Undergoing Reperfusion Therapy [Time frame: Within 24 hours of admission]
• Number of Participants With Baseline Neuroimaging Findings [Time frame: At admission (within 24 hours of hospitalization)]
• Number of Participants With Cardiac Evaluation Findings [Time frame: Within 7 days of admission]
• Modified Rankin Scale (mRS) Score at Discharge [Time frame: Day 7 post-stroke (or at discharge if earlier)]

Eligibility criteria

Inclusion criteria

• Patients aged 18 years or older diagnosed with acute or subacute ischemic stroke
• The diagnosis of stroke must be confirmed through clinical assessment and imaging examinations
• In cases where imaging examinations are negative or unavailable, the clinical diagnosis of stroke must be confirmed by an experienced neurologist. (4)Patients must sign an informed consent form agreeing to the collection of information.

Exclusion criteria

• The amount of missing data exceeds 40% of the data to be entered;
• After enrollment, it is discovered that the study participant does not meet the inclusion criteria or meets any of the exclusion criteria;
• Missing persons

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Huashan hospital Fudan University — Shanghai

Publications

• Yaghi S, Henninger N, Giles JA, Leon Guerrero C, Mistry E, Liberman AL, Asad D, Liu A, Nagy M, Kaushal A, Azher I, Mac Grory B, Fakhri H, Brown Espaillat K, Pasupuleti H, Martin H, Tan J, Veerasamy M, Esenwa C, Cheng N, Moncrieffe K, Moeini-Naghani I, Siddu M, Scher E, Trivedi T, Furie KL, Keyrouz SG, Nouh A, de Havenon A, Khan M, Smith EE, Gurol ME. Ischaemic stroke on anticoagulation therapy and PMID 33903185
• Brouwer J, Smaal JA, Emmer BJ, de Ridder IR, van den Wijngaard IR, de Leeuw FE, Hofmeijer J, van Zwam WH, Martens JM, Roos YBWEM, Majoie CB, van Oostenbrugge RJ, Coutinho JM; MR CLEAN Registry Investigatorsdagger. Endovascular Thrombectomy in Young Patients With Stroke: A MR CLEAN Registry Study. Stroke. 2022 Jan;53(1):34-42. doi: 10.1161/STROKEAHA.120.034033. Epub 2021 Dec 7. PMID 34872339
• Shu L, Akpokiere F, Mandel DM, Field TS, Leon Guerrero CR, Henninger N, Muppa J, Affan M, Haq Lodhi OU, Heldner MR, Antonenko K, Seiffge DJ, Arnold M, Salehi Omran S, Crandall R, Lester E, Lopez-Mena D, Arauz A, Nehme A, Boulanger M, Touze E, Sousa JA, Sargento-Freitas J, Barata V, Castro-Chaves P, Brito MT, Khan M, Mallick D, Rothstein A, Khazaal O, Kaufmann JE, Engelter ST, Traenka C, Aguiar de PMID 39298709
• Verhoeven JI, van Lith TJ, Ekker MS, Hilkens NA, Maaijwee NAM, Rutten-Jacobs LCA, Klijn CJM, de Leeuw FE. Long-term Risk of Bleeding and Ischemic Events After Ischemic Stroke or Transient Ischemic Attack in Young Adults. Neurology. 2022 Aug 9;99(6):e549-e559. doi: 10.1212/WNL.0000000000200808. Epub 2022 Jun 2. PMID 35654598
• Verburgt E, Hilkens NA, Ekker MS, Schellekens MMI, Boot EM, Immens MHM, van Alebeek ME, Brouwers PJAM, Arntz RM, van Dijk GW, Gons RAR, van Uden IWM, den Heijer T, van Tuijl JH, de Laat KF, van Norden AGW, Vermeer SE, van Zagten MSG, van Oostenbrugge RJ, Wermer MJH, Nederkoorn PJ, Kerkhoff H, Rooyer FA, van Rooij FG, van den Wijngaard IR, Ten Cate TJF, Tuladhar AM, de Leeuw FE, Verhoeven JI. Short PMID 38376841
• Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR; Peer Review Committe PMID 38033089
• Ekker MS, Boot EM, Singhal AB, Tan KS, Debette S, Tuladhar AM, de Leeuw FE. Epidemiology, aetiology, and management of ischaemic stroke in young adults. Lancet Neurol. 2018 Sep;17(9):790-801. doi: 10.1016/S1474-4422(18)30233-3. PMID 30129475
• Bejot Y, Daubail B, Jacquin A, Durier J, Osseby GV, Rouaud O, Giroud M. Trends in the incidence of ischaemic stroke in young adults between 1985 and 2011: the Dijon Stroke Registry. J Neurol Neurosurg Psychiatry. 2014 May;85(5):509-13. doi: 10.1136/jnnp-2013-306203. Epub 2013 Nov 18. PMID 24249786

Identifiers

NCT: NCT07171242 · KY2024-1385

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗