Clinical trial NCT04230785: Circulating Non-coding RNA in Acute Ischemic Stroke with Endovascular Treatment (EVTRNA)
Official title: Clinical Significance of Circulating Non-coding RNA in Acute Ischemic Stroke with Endovascular Treatment (EVTRNA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Stroke, Ischemic
Endovascular Treatment
Keywords: acute ischemic stroke
noncoding RNA
endovascular treatment
clinical significance
outcome
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Zhongda Hospital
First posted: 2020-01-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be 5 AIS patients, whose data before and after endovascular treatment will be applied for sequencing the differentiated expression pattern and constraction of diagnosis and predictive models of circRNA/lncRNA/miRNA from the circulating blood. There will be 300 AIS patients, whose data will be applied for validation of such diagnosis and predictive models and investigated the effect of non-coding RNA on immune status after endovascular treatment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differential expression pattern of circRNA/lncRNA/miRNA in acute ischemic stroke patients before and after endovascular treatment
timeFrame: 90 days
Secondary outcomes:
measure: Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke with endovascular treatment
timeFrame: 90 days
measure: Correlation of circRNA/lncRNA/miRNA and inflammatory factors in acute ischemic stroke with endovascular treatment
timeFrame: 90 days
measure: Correlation of circRNA/lncRNA/miRNA and stroke-associated infection
timeFrame: 90 days
measure: Dynamic changes of circRNA/lncRNA/miRNA during the follow-up period
timeFrame: 90 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Junshan Zhou, M.D
role: STUDY_CHAIR
References:
citation: 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.