Circulating Non-coding RNA in Acute Ischemic Stroke with Endovascular Treatment (EVTRNA)

Recruiting

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

• Registration Number: NCT04230785
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

EVTRNA is to analyze the differentiated expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) by next-generation sequencing in acute ischemic stroke patients before and/or after endovascular treatment. The candidate circRNA/lncRNA/miRNA will be verified as the biomarker and regulator for progression and prognosis of acute ischemic stroke with endovascular treatment. Further, the candidate non-coding RNA will be used to evaluate the effect of endovascular treatment on both peripheral and central immune after 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 differentiated expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) by next-generation sequencing in acute ischemic stroke patients before and/or after endovascular treatment. The candidate circRNA/lncRNA/miRNA will be verified as the biomarker and regulator for progression and prognosis of acute ischemic stroke with endovascular treatment. Further, the candidate non-coding RNA will be used to evaluate the effect of endovascular treatment on both peripheral and central immune after 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 predictive model will be established using logistic regression. The panel of these altered ncRNAs may be associated with the immune status after acute IS and could serve as a regulator for progression and prognosis of acute ischemic stroke with endovascular treatment.

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2020-03-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 24 hours of symptom onset and treat with endovascular therapy
• 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 before EVT group	Sequencing of circRNA/lncRNA/miRNA	This group includes patients with acute ischemic stroke (AIS) before endovascular treatment (EVT)
AIS after EVT group	Sequencing of circRNA/lncRNA/miRNA	This group includes patients with acute ischemic stroke (AIS) after endovascular treatment (EVT)

Primary Outcome Measures

Name	Time	Method
Differential expression pattern of circRNA/lncRNA/miRNA in acute ischemic stroke patients before and after endovascular treatment	90 days	Differential expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) will be compared in acute ischemic stroke patients before and after endovascular treatment, thus candidate circRNA/lncRNA/miRNA will be verified as biomarkers and regulators for progression and prognosis of acute ischemic stroke with endovascular treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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