An observational study in Ischemic Stroke, sponsored by Qiang Dong. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Qiang Dong · Observational
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.
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 15,000 is above the median of 300 across 777 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →This is the only study on the registry with Qiang Dong as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 years or older diagnosed with acute or subacute ischemic stroke
Exclusion Criteria:
Collect basic clinical information about patients, including age, gender, medical history, etc.
Patient general information
Name, age, gender, place of residence, date of admission, name of hospital, hospital grade, TOAST classification
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 30 days (from admission to discharge，this will be calculated from admission to discharge for each participant)
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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