Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175691
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

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.

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

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Clinical Significance of Circulating Non-coding RNA in Acute Ischemic Stroke (AISRNA)
Actual Study Start Date : November 24, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AIS group
This group includes patients with acute ischemic stroke (AIS).
Genetic: Sequencing of circRNA/miRNA/lncRNA
Next generation sequencing of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA)
Other Name: Quantitative Real-time polymerase chain reaction

HC group
This group includes healthy controls (HC).
Genetic: Sequencing of circRNA/miRNA/lncRNA
Next generation sequencing of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA)
Other Name: Quantitative Real-time polymerase chain reaction




Primary Outcome Measures :
  1. Differential expression pattern of circRNA/miRNA/lncRNA [ Time Frame: 90 days ]
    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.


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

  2. Correlation of circRNA/miRNA/lncRNA and inflammatory factors in acute ischemic stroke [ Time Frame: 7 days ]
    Correlation of circRNA/miRNA/lncRNA and inflammatory factors on admission will be explored in acute ischemic stroke.

  3. Correlation of circRNA/miRNA/lncRNA and stroke-associated infection [ Time Frame: 30 days ]
    Correlation of circRNA/miRNA/lncRNA and stroke-associated infection will be explored in acute ischemic stroke.

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


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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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


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): NCT04175691


Contacts
Layout table for location contacts
Contact: Junshan Zhou, M.D. +8602587726218 zhjsh333@126.com
Contact: Qiwen Deng, M.D. +8602587726218 qiw_deng@163.com

Locations
Layout table for location information
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
Investigators
Layout table for investigator information
Study Chair: Junshan Zhou, Professor Nanjing Medical University
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04175691    
Other Study ID Numbers: AISRNA
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: January 28, 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.

Layout table for additional information
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
clinical significance
outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia