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

NCT04175691 | Recruiting DMC

• 1 other identifier: AISRNA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke; Ischemic Stroke

Keywords

acute ischemic stroke; noncoding RNA; clinical significance; outcome

Outcome Measures

Primary Outcomes (1)

• Differential expression pattern of circRNA/miRNA/lncRNA

  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.

  90 days

Secondary Outcomes (4)

• Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke

  90 days

• Correlation of circRNA/miRNA/lncRNA and inflammatory factors in acute ischemic stroke

  7 days

• Correlation of circRNA/miRNA/lncRNA and stroke-associated infection

  30 days

• Dynamic changes of circRNA/miRNA/lncRNA during the follow-up period

  90 days

Study Arms (2)

AIS group

This group includes patients with acute ischemic stroke (AIS).

Genetic: Sequencing of circRNA/miRNA/lncRNA

HC group

This group includes healthy controls (HC).

Genetic: Sequencing of circRNA/miRNA/lncRNA

Interventions

Sequencing of circRNA/miRNA/lncRNA GENETIC

Next generation sequencing of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA)

Also known as: Quantitative Real-time polymerase chain reaction

AIS group; HC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 29997237 RESULT

• 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.

  PMID: 32337817 RESULT

• Chen W, Zhang H, Li Z, Deng Q, Wang M, Chen Y, Zhang Y. Effects of edaravone dexborneol on functional outcome and inflammatory response in patients with acute ischemic stroke. BMC Neurol. 2024 Jun 20;24(1):209. doi: 10.1186/s12883-024-03712-1.

  PMID: 38902691 DERIVED

• 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.

  PMID: 34980176 DERIVED

• 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.

  PMID: 34511974 DERIVED

Related Links

• Differential Long Noncoding RNA Expressions in Peripheral Blood Mononuclear Cells for Detection of Acute Ischemic Stroke

Biospecimen

Retention: SAMPLES WITH DNA

An 10 ml peripheral venous blood will be collected from the participants before and after interventions (i.e. intravenous thrombolysis and/or endovascular therapy)

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Real-Time Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Junshan Zhou, Professor

  Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Junshan Zhou, M.D.

CONTACT

+8602587726218; zhjsh333@126.com

Qiwen Deng, M.D.

CONTACT

+8602587726218; qiw_deng@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: November 24, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: All information will be available to all researchers when related investigation has been accepted publicly, and will be available for 5 years.
• Access Criteria: All information will be available to all researchers when related investigation has been accepted publicly.

Locations

CN (1)