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NCT Number: NCT07171242

Shanghai Prospective Registry Study of Ischemic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Qiang Dong, Professor

CONTACT

[email protected]

+8613701747065

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient general information

    Time frame: Upon admission

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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiang Dong, Professor

CONTACT

[email protected]

+8613701747065

Sponsors and collaborators

Lead sponsor

Qiang Dong

Other

Registry information

Acronym: 4S

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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