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Clinical Trials/NCT07171242
NCT07171242RecruitingNot Applicable

Shanghai Prospective Registry Study of Ischemic Stroke

Qiang Dong1 site in 1 country15,000 target enrollmentStarted: December 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
15,000
Locations
1
Primary Endpoint
Patient general information

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Patient general information

Time Frame: 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)

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

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Qiang Dong
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Qiang Dong

Director

Huashan Hospital

Study Sites (1)

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