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

NCT04230785 | Recruiting

• 1 other identifier: EVTRNA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Stroke, Ischemic; Endovascular Treatment

Keywords

acute ischemic stroke; noncoding RNA; endovascular treatment; clinical significance; outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  90 days

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

  90 days

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

  90 days

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

  90 days

Study Arms (2)

AIS before EVT group

This group includes patients with acute ischemic stroke (AIS) before endovascular treatment (EVT)

Genetic: Sequencing of circRNA/lncRNA/miRNA

AIS after EVT group

This group includes patients with acute ischemic stroke (AIS) after endovascular treatment (EVT)

Genetic: Sequencing of circRNA/lncRNA/miRNA

Interventions

Sequencing of circRNA/lncRNA/miRNA GENETIC

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

Also known as: Quantitative Real-time polymerase chain reaction

AIS after EVT group; AIS before EVT group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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 24 hours of symptom onset and treat with endovascular therapy
• 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
• Zhongda Hospital: collaborator

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

Related 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.

  PMID: 29997237 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

An 10 ml peripheral venous blood will be collected from the participants before and after endovascular treatment

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, M.D

  Nanjing First Hospital, 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: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: March 15, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 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)