Shanghai Prospective Registry Study of Ischemic Stroke

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Patient general information — Upon admission
  Name, age, gender, place of residence, date of admission, name of hospital, hospital grade, TOAST classification
• Risk factors (assessed by medical history review and clinical evaluation) — 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
• Pre-illness medication history（assessed by medical history review） — 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.
• Baseline National Institutes of Health Stroke Scale (NIHSS) Score — 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.
• Pre-Stroke Modified Rankin Scale (mRS) Score — 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.
• Time Metrics from Symptom Onset to Hospital Presentation — 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.
• Number of Participants Undergoing Reperfusion Therapy — 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.
• Number of Participants With Baseline Neuroimaging Findings — 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.
• Number of Participants With Cardiac Evaluation Findings — 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).
• Modified Rankin Scale (mRS) Score at Discharge — 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.
• Discharge Diagnosis — 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.
• Length of Hospital Stay — 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.

Trial sites (1)

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