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

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ClinicalTrials.gov Identifier: NCT04230785
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : May 26, 2021
Sponsor:
Collaborator:
Zhongda Hospital
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

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.

Condition or disease Intervention/treatment
Stroke, Acute Stroke, Ischemic Endovascular Treatment Genetic: Sequencing of circRNA/lncRNA/miRNA

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Clinical Significance of Circulating Non-coding RNA in Acute Ischemic Stroke With Endovascular Treatment (EVTRNA)
Actual Study Start Date : March 15, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AIS before EVT group
This group includes patients with acute ischemic stroke (AIS) before endovascular treatment (EVT)
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)
Other Name: Quantitative Real-time polymerase chain reaction

AIS after EVT group
This group includes patients with acute ischemic stroke (AIS) after endovascular treatment (EVT)
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)
Other Name: Quantitative Real-time polymerase chain reaction




Primary Outcome Measures :
  1. Differential expression pattern of circRNA/lncRNA/miRNA in acute ischemic stroke patients before and after endovascular treatment [ Time Frame: 90 days ]
    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.


Secondary Outcome Measures :
  1. Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke with endovascular treatment [ Time Frame: 90 days ]
    The prognosis of AIS patients will be analyzed between differential expressed candidate circRNA/lncRNA/miRNA after they have endovascular treatment.

  2. Correlation of circRNA/lncRNA/miRNA and inflammatory factors in acute ischemic stroke with endovascular treatment [ Time Frame: 90 days ]
    Correlation of circRNA/lncRNA/miRNA and inflammatory factors in acute ischemic stroke before and after endovascular treatment will be explored.

  3. Correlation of circRNA/lncRNA/miRNA and stroke-associated infection [ Time Frame: 90 days ]
    Correlation of circRNA/lncRNA/miRNA and stroke-associated infection will be explored in acute ischemic stroke with endovascular treatment.

  4. Dynamic changes of circRNA/lncRNA/miRNA during the follow-up period [ Time Frame: 90 days ]
    Dynamic changes of circRNA/lncRNA/miRNA will be explored after endovascular therapy during the follow-up period


Biospecimen Retention:   Samples With DNA
An 10 ml peripheral venous blood will be collected from the participants before and after endovascular treatment


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230785


Contacts
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Contact: Junshan Zhou, M.D +8602587726218 zhjsh333@126.com
Contact: Qiwen Deng, M.D +8602587726218 qiw_deng@163.com

Locations
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China, Jiangsu
Nanjing First Hospital, Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Junshan Zhou, M.D.    +86025-87726218    zhjsh333@126.com   
Contact: Qiwen Deng, M.D.    +86025-87726218    qiw_deng@163.com   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Zhongda Hospital
Investigators
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Study Chair: Junshan Zhou, M.D Nanjing First Hospital, Nanjing Medical University
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04230785    
Other Study ID Numbers: EVTRNA
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All information will be available to all researchers
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanjing First Hospital, Nanjing Medical University:
acute ischemic stroke
noncoding RNA
endovascular treatment
clinical significance
outcome
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes