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NCT04175691 Clinical Trial

Circulating Non-coding RNA in Acute Ischemic Stroke (AISRNA)

Ischemic Stroke Clinical Trial

— AISRNA  

Official title:
Clinical Significance of Circulating Non-coding RNA in Acute Ischemic Stroke (AISRNA)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04175691
Other study ID # AISRNA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 24, 2019
Est. completion date December 31, 2024

Study information
Verified date April 2023
Source Nanjing First Hospital, Nanjing Medical University
Contact Junshan Zhou, M.D.
Phone +8602587726218
Email zhjsh333@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

AISRNA is to analyze the expression pattern of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with acute ischemic stroke and healthy control. The candidate circRNA/miRNA/lncRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke.

Description:

Noncoding 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), micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with acute ischemic stroke and healthy control. The candidate circRNA/miRNA/lncRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke. Distinctive expression patterns of circRNA/miRNA/lncRNA will be identified by the next-generation sequencing and 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 ncRNAs 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 December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers 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

Related Conditions & MeSH terms

Intervention

Genetic:
• Sequencing of circRNA/miRNA/lncRNA
Next generation sequencing of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA)

Locations
Country Name City State
China Nanjing First Hospital, Nanjing Medical University Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Deng QW, Li S, Wang H, Sun HL, Zuo L, Gu ZT, Lu G, Sun CZ, Zhang HQ, Yan FL. Differential long noncoding RNA expressions in peripheral blood mononuclear cells for detection of acute ischemic stroke. Clin Sci (Lond). 2018 Jul 31;132(14):1597-1614. doi: 10. — View Citation

Li S, Lu G, Wang D, He JL, Zuo L, Wang H, Gu ZT, Zhou JS, Yan FL, Deng QW. MicroRNA-4443 regulates monocyte activation by targeting tumor necrosis factor receptor associated factor 4 in stroke-induced immunosuppression. Eur J Neurol. 2020 Aug;27(8):1625-1 — View Citation

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