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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05098340
Other study ID # XYFY2021-KL107-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date September 30, 2024

Study information

Verified date October 2021
Source The Affiliated Hospital of Xuzhou Medical University
Contact Xingzhi Wang, MD
Phone 0086-13852000759
Email wxz1220@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

CRAST is to analyze the expression pattern of circular RNA (circRNA) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. The candidate circRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke.


Description:

Circular RNAs have been highlighted to be involved in the pathological process of ischemic stroke (IS). The purpose of this protocol will investigate the expression pattern of circular RNA (circRNA) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. The candidate circRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke. Distinctive expression patterns of circRNA will be identified by individual quantitative real time polymerase chain reaction (qRT-PCR). A diagnostic or predictive model will be established using logistic regression. The panel of these altered circRNAs may be associated with acute IS and could serve as a novel diagnostic or predictive method.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18 years or older - Confirmed acute ischemic stroke by a diffusion-weighted imaging-position lesion on magnetic resonance imaging (MRI) and a new lesion on a brain computed tomography (CT) scan - Within 72 hours of symptom onset - Good performance status - Signed an approved informed consents Exclusion Criteria: - a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases

Study Design


Intervention

Genetic:
Quantitative Real-time polymerase chain reaction
Quantitative Real-time polymerase chain reaction of circular RNA (circRNA).

Locations

Country Name City State
China Department of Neurology Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differential expression pattern of circRNA Differential expression pattern of circular RNA (circRNA) will be compared between AIS group and HC group, thus candidate circRNA will be verified as biomarkers for the detection and prognosis of AIS. 90 days
Secondary Dynamic changes of circRNA during the follow-up period Dynamic changes of circRNA will be explored before and after endovascular therapy 90 days
Secondary Correlation of circRNA and stroke-associated infection Correlation of circRNA and stroke-associated infection will be explored in acute ischemic stroke. 30 days
Secondary Correlation of circRNA and inflammatory factors in acute ischemic stroke Correlation of circRNA and inflammatory factors on admission will be explored in acute ischemic stroke. 7 days
Secondary Prognostic value of circRNA in acute ischemic stroke The prognosis of AIS patients will be analyzed between differential expressed candidate circRNA after they have completed the systematic therapy. 90 days
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