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

Stroke, Acute Clinical Trial

— EVTRNA  

Official title:

Clinical Significance of Circulating Non-coding RNA in Acute Ischemic Stroke With Endovascular Treatment (EVTRNA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230785
• Other study ID #: EVTRNA
• Status: Recruiting
• Start date: March 15, 2020
• Est. completion date: March 1, 2025

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
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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 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

Related Conditions & MeSH terms

• Endovascular Treatment
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

Genetic:
• Sequencing of circRNA/lncRNA/miRNA
Next generation sequencing and quantitative real-time polymerase chain reaction of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University	Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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: 10.1042/CS20180411. Print 2018 Jul 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential expression pattern of circRNA/lncRNA/miRNA in acute ischemic stroke patients before and after endovascular treatment	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.	90 days
Secondary	Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke with endovascular treatment	The prognosis of AIS patients will be analyzed between differential expressed candidate circRNA/lncRNA/miRNA after they have endovascular treatment.	90 days
Secondary	Correlation of circRNA/lncRNA/miRNA and inflammatory factors in acute ischemic stroke with endovascular treatment	Correlation of circRNA/lncRNA/miRNA and inflammatory factors in acute ischemic stroke before and after endovascular treatment will be explored.	90 days
Secondary	Correlation of circRNA/lncRNA/miRNA and stroke-associated infection	Correlation of circRNA/lncRNA/miRNA and stroke-associated infection will be explored in acute ischemic stroke with endovascular treatment.	90 days
Secondary	Dynamic changes of circRNA/lncRNA/miRNA during the follow-up period	Dynamic changes of circRNA/lncRNA/miRNA will be explored after endovascular therapy during the follow-up period	90 days