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

Recruiting

• Conditions: Acute Stroke; Ischemic Stroke
• Interventions: Genetic: Sequencing of circRNA/miRNA/lncRNA

• Registration Number: NCT04175691
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Study Start: 2019-11-24
• Study First Posted: 2019-11-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AIS group	Sequencing of circRNA/miRNA/lncRNA	This group includes patients with acute ischemic stroke (AIS).
HC group	Sequencing of circRNA/miRNA/lncRNA	This group includes healthy controls (HC).

Primary Outcome Measures

Name	Time	Method
Differential expression pattern of circRNA/miRNA/lncRNA	90 days	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.

Secondary Outcome Measures

Name	Time	Method
Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke	90 days	The prognosis of AIS patients will be analyzed between differential expressed candidate miRNA/lncRNA after they have completed the systematic therapy.
Correlation of circRNA/miRNA/lncRNA and inflammatory factors in acute ischemic stroke	7 days	Correlation of circRNA/miRNA/lncRNA and inflammatory factors on admission will be explored in acute ischemic stroke.
Correlation of circRNA/miRNA/lncRNA and stroke-associated infection	30 days	Correlation of circRNA/miRNA/lncRNA and stroke-associated infection will be explored in acute ischemic stroke.
Dynamic changes of circRNA/miRNA/lncRNA during the follow-up period	90 days	Dynamic changes of circRNA/miRNA/lncRNA will be explored before and after endovascular therapy

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China