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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06165107
Other study ID # TJ-IRB20230830
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date January 31, 2022

Study information

Verified date December 2023
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study population comprised patients experiencing acute first-ever ischaemic stroke, with diagnostic criteria established in accordance with the International Classification of Diseases, Ninth Revision. All subjects presented rigorous neuroimaging evidence, including head computed tomography and/or magnetic resonance imaging, which underwent review by two or more experienced neuroradiologists. Adverse outcomes were characterized as compliant endpoint events, encompassing mortality and recurrences. The primary outcome was adverse outcomes and the secondary outcome was recurrence-free survival (RFS).


Description:

Clinical data for the derivation cohort were acquired from three medical facilities: Tongji Hospital Sino-French New City Branch in Caidian District, Tongji Hospital Qiaokou Branch in Hankou District, and Tongji Hospital Optics Valley Branch in Wuhan East Lake High-Tech Development Zone. The clinical data were sourced from the electronic medical records of Tongji Hospital, the largest healthcare facility in the Hubei region of China. Its comprehensive electronic medical record system comprises over 60 million medical records spanning from 1980 to the present. We retrospectively gathered information on patients admitted for acute first-ever ischaemic stroke between January 2012 and January 2022. The following individuals were excluded from the study: 1) Those under 18 years of age; and 2) Pregnant women. The variables gathered included the primary test parameters of patients within 24 hours of admission, encompassing age, gender, smoking and alcohol consumption status, arterial blood pressure, fat-related indicators, comorbidities, and the primary treatments administered within the initial 24 hours.


Recruitment information / eligibility

Status Completed
Enrollment 45162
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - We retrospectively gathered information on patients admitted for acute first-ever ischaemic stroke between January 2012 and January 2022. Exclusion Criteria: 1. Those under 18 years of age; and 2) Pregnant women.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Qin Zhang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Death 10 years
Primary Recurrence Recurrent stroke 10 years
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