Shanghai Prospective Registry Study of Ischemic Stroke (4S)

September 9, 2025 updated by: Qiang Dong
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Patients aged 18 years or older diagnosed with acute or subacute ischemic stroke
  2. The diagnosis of stroke must be confirmed through clinical assessment and imaging examinations
  3. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
acute ischemic stroke group
Collect basic clinical information about patients, including age, gender, medical history, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient general information
Time Frame: Upon admission
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)
Time Frame: Upon admission
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）
Time Frame: Upon admission
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
Time Frame: Upon admission
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
Time Frame: Prior to stroke admission (assessed upon current admission)
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
Time Frame: Upon admission
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
Time Frame: Within 24 hours of admission
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
Time Frame: At admission (within 24 hours of hospitalization)
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
Time Frame: Within 7 days of admission
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
Time Frame: Day 7 post-stroke (or at discharge if earlier)
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
Time Frame: Day 7 post-stroke (or at discharge if earlier)
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
Time Frame: Up to 30 days (from admission to discharge，this will be calculated from admission to discharge for each participant)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qiang Dong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

August 25, 2025

First Submitted That Met QC Criteria

September 9, 2025

First Posted (Estimated)

September 12, 2025

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024-1385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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