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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

Tracking Information
First Submitted Date January 14, 2020
First Posted Date January 18, 2020
Last Update Posted Date May 26, 2021
Actual Study Start Date March 15, 2020
Estimated Primary Completion Date March 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 14, 2020)
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 90 Days
Biospecimen Retention:   Samples With DNA
Description:
An 10 ml peripheral venous blood will be collected from the participants before and after endovascular treatment
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.
Condition
  • Stroke, Acute
  • Stroke, Ischemic
  • Endovascular Treatment
Intervention 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
Study Groups/Cohorts
  • AIS before EVT group
    This group includes patients with acute ischemic stroke (AIS) before endovascular treatment (EVT)
    Intervention: Genetic: Sequencing of circRNA/lncRNA/miRNA
  • AIS after EVT group
    This group includes patients with acute ischemic stroke (AIS) after endovascular treatment (EVT)
    Intervention: Genetic: Sequencing of circRNA/lncRNA/miRNA
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 14, 2020)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2025
Estimated Primary Completion Date March 1, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Junshan Zhou, M.D +8602587726218 zhjsh333@126.com
Contact: Qiwen Deng, M.D +8602587726218 qiw_deng@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04230785
Other Study ID Numbers EVTRNA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Nanjing First Hospital, Nanjing Medical University
Study Sponsor Nanjing First Hospital, Nanjing Medical University
Collaborators Zhongda Hospital
Investigators
Study Chair: Junshan Zhou, M.D Nanjing First Hospital, Nanjing Medical University
PRS Account Nanjing First Hospital, Nanjing Medical University
Verification Date January 2021