Shanghai Prospective Registry Study of Ischemic Stroke

NCT07171242 | Recruiting

• 1 other identifier: KY2024-1385
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke

Outcome Measures

Primary Outcomes (12)

• Patient general information

  Name, age, gender, place of residence, date of admission, name of hospital, hospital grade, TOAST classification

  Upon admission

• Risk factors (assessed by medical history review and clinical evaluation)

  The presence (Yes) or absence (No) of each listed risk factor will be determined for each participant through medical history review and clinical evaluation：Smoking, hypertension, atrial fibrillation, hyperlipidemia, diabetes, history of cerebral infarction, myocardial infarction, other heart diseases, dementia, chronic obstructive pulmonary disease, history of bleeding or bleeding tendency

  Upon admission

• Pre-illness medication history（assessed by medical history review）

  The use of the following pre-illness medication categories, as confirmed by medical history review upon admission, will be recorded as a binary outcome (Yes/No) for each participant: antihypertensive drugs, antidiabetic drugs, lipid-lowering drugs, anticoagulants, antiplatelet drugs.

  Upon admission

• Baseline National Institutes of Health Stroke Scale (NIHSS) Score

  The severity of neurological deficit will be assessed using the National Institutes of Health Stroke Scale (NIHSS) upon admission. The NIHSS is a 15-item neurologic examination stroke scale with scores ranging from 0 to 42, where higher scores indicate more severe neurological deficit.

  Upon admission

• Pre-Stroke Modified Rankin Scale (mRS) Score

  Functional ability prior to stroke admission will be assessed using the Modified Rankin Scale (mRS). The mRS is a 6-point disability scale ranging from 0 (no symptoms) to 5 (severe disability), with a separate score of 6 indicating death. Higher scores indicate worse functional outcome.

  Prior to stroke admission (assessed upon current admission)

• Time Metrics from Symptom Onset to Hospital Presentation

  The following time points will be recorded to determine delays in presentation: time when the patient was last known to be at their normal neurological baseline, time of symptom onset, and time of arrival at the hospital.

  Upon admission

• Number of Participants Undergoing Reperfusion Therapy

  The administration of specific reperfusion therapies during hospitalization will be recorded as a binary outcome (Yes/No) for each participant. Therapies include: intravenous thrombolysis and endovascular treatment (mechanical thrombectomy). Determination will be made through review of medical records and procedure documentation.

  Within 24 hours of admission

• Number of Participants With Baseline Neuroimaging Findings

  The presence of findings on baseline neuroimaging (CT or MRI) performed at admission will be recorded. This includes the presence of cerebral small vessel disease manifestations (e.g., white matter hyperintensities, lacunes) and the location and degree of large vessel occlusion/stenosis.

  At admission (within 24 hours of hospitalization)

• Number of Participants With Cardiac Evaluation Findings

  Results from cardiac evaluations performed during hospitalization will be recorded as binary outcomes (normal/abnormal). Assessments include: echocardiogram (cardiac ultrasound), electrocardiogram (ECG), 24-hour Holter monitoring, and bubble test (for patent foramen ovale detection).

  Within 7 days of admission

• Modified Rankin Scale (mRS) Score at Discharge

  Functional outcome at discharge will be assessed using the Modified Rankin Scale (mRS). The mRS is a 7-point disability scale ranging from 0 (no symptoms) to 6 (death), where higher scores indicate worse functional outcome.

  Day 7 post-stroke (or at discharge if earlier)

• Discharge Diagnosis

  The primary diagnosis documented in the medical record at the time of hospital discharge will be recorded.

  Day 7 post-stroke (or at discharge if earlier)

• Length of Hospital Stay

  The duration of hospitalization, calculated as the number of days from admission to discharge.

  Up to 30 days (from admission to discharge，this will be calculated from admission to discharge for each participant)

Study Arms (1)

acute ischemic stroke group

Collect basic clinical information about patients, including age, gender, medical history, etc.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 years or older diagnosed with acute or subacute ischemic stroke

You may qualify if:

• 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.

You may not qualify if:

• The amount of missing data exceeds 40% of the data to be entered;
• Missing persons

Sponsors & Collaborators

• Qiang Dong: lead

Study Sites (1)

Huashan hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (10)

• 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 early recurrence in acute cardioembolic stroke: the IAC study. J Neurol Neurosurg Psychiatry. 2021 Oct;92(10):1062-1067. doi: 10.1136/jnnp-2021-326166. Epub 2021 Apr 26.

  PMID: 33903185 RESULT

• 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 RESULT

• 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 Sousa D, Soares MD, Rosa SB, Zhou L, Gandhi P, Mancini S, Metanis I, Leker RR, Pan K, Dantu V, Baumgartner K, Burton TM, Von Rennenberg R, Nolte CH, Choi R, MacDonald J, Bavarsad Shahripour R, Guo X, Ghannam M, Almajali M, Samaniego EA, Rioux B, Zine-Eddine F, Poppe A, Fonseca AC, Baptista MF, Cruz D, Romoli M, De Marco G, Longoni M, Keser Z, Griffin KJ, Kuohn L, Frontera JA, Amar JY, Giles JA, Zedde M, Pascarella R, Grisendi I, Nzwalo H, Liebeskind DS, Molaie A, Cavalier A, Kam W, Mac Grory B, Al Kasab S, Anadani M, Kicielinski KP, Eltatawy A, Chervak L, Chulluncuy Rivas R, Aziz YN, Mistry EA, Bakradze E, Tran TL, Rodrigo-Gisbert M, Requena M, Saleh Velez FG, Garcia JO, Muddasani V, de Havenon A, Sanchez S, Vishnu VY, Yaddanapudi S, Adams L, Browngoehl A, Ranasinghe T, Dunston R, Lynch Z, Penckofer M, Siegler JE, Mayer S, Willey JZ, Zubair AS, Cheng YK, Sharma R, Marto JP, Krupka D, Klein P, Nguyen TN, Asad SD, Sarwat Z, Balabhadra A, Patel S, Secchi T, Martins SC, Mantovani GP, Kim YD, Krishnaiah B, Elangovan C, Lingam S, Qureshi AY, Fridman S, Alvarado A, Khasiyev F, Linares G, Mannino M, Terruso V, Tountopoulou A, Tentolouris-Piperas V, Martinez-Marino MM, Carrasco Wall V, Indraswari F, El Jamal SE, Liu S, Zhou M, Alvi MM, Ali F, Sarvath M, Morsi RZ, Kass-Hout T, Shi F, Zhang J, Sokhi D, Said J, Mongare N, Simpkins AN, Gomez R, Sen S, Ghani M, Elnazeir M, Wangqin R, Xiao H, Kala NS, Khan F, Stretz C, Mohammadzadeh N, Goldstein ED, Furie K, Yaghi S. Intravenous Thrombolysis in Patients With Cervical Artery Dissection: A Secondary Analysis of the STOP-CAD Study. Neurology. 2024 Oct 8;103(7):e209843. doi: 10.1212/WNL.0000000000209843. Epub 2024 Sep 19.

  PMID: 39298709 RESULT

• 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 RESULT

• 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-Term and Long-Term Risk of Recurrent Vascular Event by Cause After Ischemic Stroke in Young Adults. JAMA Netw Open. 2024 Feb 5;7(2):e240054. doi: 10.1001/jamanetworkopen.2024.0054.

  PMID: 38376841 RESULT

• 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 Committee Members. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30.

  PMID: 38033089 RESULT

• 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 RESULT

• 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 RESULT

• Ekker MS, Verhoeven JI, Vaartjes I, van Nieuwenhuizen KM, Klijn CJM, de Leeuw FE. Stroke incidence in young adults according to age, subtype, sex, and time trends. Neurology. 2019 May 21;92(21):e2444-e2454. doi: 10.1212/WNL.0000000000007533. Epub 2019 Apr 24.

  PMID: 31019103 RESULT

• Madsen TE, Khoury JC, Leppert M, Alwell K, Moomaw CJ, Sucharew H, Woo D, Ferioli S, Martini S, Adeoye O, Khatri P, Flaherty M, De Los Rios La Rosa F, Mackey J, Mistry E, Demel SL, Coleman E, Jasne A, Slavin SJ, Walsh K, Star M, Broderick JP, Kissela BM, Kleindorfer DO. Temporal Trends in Stroke Incidence Over Time by Sex and Age in the GCNKSS. Stroke. 2020 Apr;51(4):1070-1076. doi: 10.1161/STROKEAHA.120.028910. Epub 2020 Feb 12.

  PMID: 32078459 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Qiang Dong, Professor

CONTACT

+8613701747065; qiang_dong163@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 12, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)