Clinical trial NCT04175691: Circulating Non-coding RNA in Acute Ischemic Stroke (AISRNA)
Official title: Clinical Significance of Circulating Non-coding RNA in Acute Ischemic Stroke (AISRNA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Stroke
Ischemic Stroke
Keywords: acute ischemic stroke
noncoding RNA
clinical significance
outcome
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be 5 AIS patients and 5 HCs, whose data will be applied for construction of diagnostic and predictive models of circRNA/miRNA/lncRNA from the circulating blood. There will be 100 patients suspected of AIS (such as transient ischemic attack) 300 AIS patients, whose data will be applied for validation of such diagnosis and predictive models, respectively.

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.

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 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

Primary outcomes:
measure: Differential expression pattern of circRNA/miRNA/lncRNA
timeFrame: 90 days
Secondary outcomes:
measure: Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke
timeFrame: 90 days
measure: Correlation of circRNA/miRNA/lncRNA and inflammatory factors in acute ischemic stroke
timeFrame: 7 days
measure: Correlation of circRNA/miRNA/lncRNA and stroke-associated infection
timeFrame: 30 days
measure: Dynamic changes of circRNA/miRNA/lncRNA 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 Medical University
name: Junshan Zhou, Professor
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.
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):1625-1637. doi: 10.1111/ene.14282. Epub 2020 May 18.
citation: Sun H, Li S, Xu Z, Liu C, Gong P, Deng Q, Yan F. SNHG15 is a negative regulator of inflammation by mediating TRAF2 ubiquitination in stroke-induced immunosuppression. J Neuroinflammation. 2022 Jan 3;19(1):1. doi: 10.1186/s12974-021-02372-z.
citation: Deng QW, Huang S, Li S, Zhai Q, Zhang Q, Wang ZJ, Chen WX, Sun H, Lu M, Zhou J. Inflammatory Factors as Potential Markers of Early Neurological Deterioration in Acute Ischemic Stroke Patients Receiving Endovascular Therapy - The AISRNA Study. J Inflamm Res. 2021 Sep 2;14:4399-4407. doi: 10.2147/JIR.S317147. eCollection 2021.