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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05345366
Other study ID # 2021LX0027-GC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date March 1, 2024

Study information

Verified date April 2022
Source Zhujiang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the imaging examination. At present, there is no effective and sensitive biomarker for collateral circulation. Thus, the research objective was to evaluate the predicting role of the CBP/P300-interacting transactivator with Glu/Asp-rich C-terminal domain 2 Ratio (CITED2) from peripheral blood mononuclear cells in the collateral circulation of AIS. We classified the AIS patients into two groups (the good collateral group and the poor collateral group) by DWI-ASPECTS score. The western blot was applied to test the protein expression of vascular endothelial growth factor (VEGF) and CITED2. Then, we collected other clinical data. Binary logistic regression analysis between collateral circulation and clinical data was performed. Finally, Receiver operating characteristic (ROC) curve analysis was used to explore the predictive value of the CITED2.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date March 1, 2024
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - the first-time onset or previous stroke with mRS score =1, and the onset time less than 3 days without intravenous thrombolysis or endovascular therapy ; - age range of 18 to 80 years old; - patients with a clinical diagnosis of acute ischemic stroke; ? NIHSS score =4; ? patients volunteer to participate in this study and signed a written informed consent Exclusion Criteria: - ?the patients with AIS combined with other diseases that may affect the CITED2 and VEGF expression, such as acute myocardial infarction, peripheral artery occlusion disease and congenital heart defect; - the patients exhibited serious heart, live or kidney diseases; ?disturbance of consciousness or mental illness; ? patients with tumor; ? pregnant and lactating patients.

Study Design


Intervention

Other:
non-applicable
non-applicable

Locations

Country Name City State
China Zhujiang Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CITED2 western blot/ELISA within 24 hours after hospitalization
Primary VEGF western blot/ELISA within 24 hours after hospitalization
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