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

April 9, 2023 updated by: Nanjing First Hospital, Nanjing Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing First Hospital, Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Quantitative Real-time polymerase chain reaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days
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.
7 days
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.
30 days
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Junshan Zhou, Professor, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2019

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AISRNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All information will be available to all researchers.

IPD Sharing Time Frame

All information will be available to all researchers when related investigation has been accepted publicly, and will be available for 5 years.

IPD Sharing Access Criteria

All information will be available to all researchers when related investigation has been accepted publicly.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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