Acute StrokeAISRNANCT04175691
Circulating Non-coding RNA in Acute Ischemic Stroke (AISRNA)
An observational study of Acute Stroke and Ischemic Stroke, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Stroke, Ischemic Stroke
- What is being tested?
- Sequencing of circRNA/miRNA/lncRNA
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2019to 31 Dec 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
Junshan Zhou, M.D., +86025-87726218, zhjsh333@126.com
Qiwen Deng, M.D., +86025-87726218, qiw_deng@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Stroke, Ischemic Stroke
- Being tested
- Sequencing of circRNA/miRNA/lncRNA
- Keywords
- acute ischemic stroke, noncoding RNA, clinical significance, outcome
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequencing of circRNA/miRNA/lncRNAGenetic
Also called Quantitative Real-time polymerase chain reaction
Next generation sequencing of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA)
| Study group | Role | What they receive |
|---|---|---|
| AIS group | This group includes patients with acute ischemic stroke (AIS). Receives: Genetic: Sequencing of circRNA/miRNA/lncRNA | |
| HC group | This group includes healthy controls (HC). Receives: Genetic: Sequencing of circRNA/miRNA/lncRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential expression pattern of circRNA/miRNA/lncRNA
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.
Measured: 90 days
Secondary outcomes (4)
Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke
The prognosis of AIS patients will be analyzed between differential expressed candidate miRNA/lncRNA after they have completed the systematic therapy.
Measured: 90 days
Correlation of circRNA/miRNA/lncRNA and inflammatory factors in acute ischemic stroke
Correlation of circRNA/miRNA/lncRNA and inflammatory factors on admission will be explored in acute ischemic stroke.
Measured: 7 days
Correlation of circRNA/miRNA/lncRNA and stroke-associated infection
Correlation of circRNA/miRNA/lncRNA and stroke-associated infection will be explored in acute ischemic stroke.
Measured: 30 days
Dynamic changes of circRNA/miRNA/lncRNA during the follow-up period
Dynamic changes of circRNA/miRNA/lncRNA will be explored before and after endovascular therapy
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start24 Nov 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junshan Zhou, Professor, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175691
- Sponsor's protocol ID
- AISRNA
- Acronym
- AISRNA
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2019
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information will be available to all researchers.
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.
PubMed 29997237Li S, Lu G, Wang D, He JL, Zuo L, Wang H, Gu ZT, Zhou JS, Yan FL, Deng QW. MicroRNA-4443 regulates monocyte activation by targeting tumor necrosis factor receptor associated factor 4 in stroke-induced immunosuppression. Eur J Neurol. 2020 Aug;27(8):1625-1637. doi: 10.1111/ene.14282. Epub 2020 May 18.
PubMed 32337817Li Z, Liu X, Sun H, Jiang X, Zhang Y, Ji L, Zhang L, Wang M, Gu M, Li S, Zhang Y, Liu Y, Shi H, Jiang T, Mei Y, Zhu L, Zhou J, Deng Q. Predictors for recurrent ischemic stroke in patients with watershed infarct induced by intracranial artery stenosis. Clin Neurol Neurosurg. 2025 Jul;254:108897. doi: 10.1016/j.clineuro.2025.108897. Epub 2025 Apr 18.
PubMed 40288288Chen W, Zhang H, Li Z, Deng Q, Wang M, Chen Y, Zhang Y. Effects of edaravone dexborneol on functional outcome and inflammatory response in patients with acute ischemic stroke. BMC Neurol. 2024 Jun 20;24(1):209. doi: 10.1186/s12883-024-03712-1.
PubMed 38902691Sun H, Li S, Xu Z, Liu C, Gong P, Deng Q, Yan F. SNHG15 is a negative regulator of inflammation by mediating TRAF2 ubiquitination in stroke-induced immunosuppression. J Neuroinflammation. 2022 Jan 3;19(1):1. doi: 10.1186/s12974-021-02372-z.
PubMed 34980176Deng QW, Huang S, Li S, Zhai Q, Zhang Q, Wang ZJ, Chen WX, Sun H, Lu M, Zhou J. Inflammatory Factors as Potential Markers of Early Neurological Deterioration in Acute Ischemic Stroke Patients Receiving Endovascular Therapy - The AISRNA Study. J Inflamm Res. 2021 Sep 2;14:4399-4407. doi: 10.2147/JIR.S317147. eCollection 2021.
PubMed 34511974
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Circulating Non-coding RNA in Acute Ischemic Stroke (AISRNA)
- ClinicalTrials.gov ID
- NCT04175691
- Acronym / sponsor ID
- AISRNA / AISRNA
- Conditions
- Acute Stroke, Ischemic Stroke
- Keywords
- acute ischemic stroke, noncoding RNA, clinical significance, outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 24 Nov 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS group | – | Genetic: Sequencing of circRNA/miRNA/lncRNAThis group includes patients with acute ischemic stroke (AIS). |
| HC group | – | Genetic: Sequencing of circRNA/miRNA/lncRNAThis group includes healthy controls (HC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequencing of circRNA/miRNA/lncRNAAlso: Quantitative Real-time polymerase chain reactionNext generation sequencing of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA) | Genetic | AIS group, HC group |
Primary outcome
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.
4 secondary outcomes
Prognostic value of circRNA/miRNA/lncRNA in acute ischemic stroke
Time frame: 90 days
Correlation of circRNA/miRNA/lncRNA and inflammatory factors in acute ischemic stroke
Time frame: 7 days
Correlation of circRNA/miRNA/lncRNA and stroke-associated infection
Time frame: 30 days
Dynamic changes of circRNA/miRNA/lncRNA during the follow-up period
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Results publication: PubMed 29997237Deng 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.
- Results publication: PubMed 32337817Li S, Lu G, Wang D, He JL, Zuo L, Wang H, Gu ZT, Zhou JS, Yan FL, Deng QW. MicroRNA-4443 regulates monocyte activation by targeting tumor necrosis factor receptor associated factor 4 in stroke-induced immunosuppression. Eur J Neurol. 2020 Aug;27(8):1625-1637. doi: 10.1111/ene.14282. Epub 2020 May 18.
- Derived from this study: PubMed 40288288Li Z, Liu X, Sun H, Jiang X, Zhang Y, Ji L, Zhang L, Wang M, Gu M, Li S, Zhang Y, Liu Y, Shi H, Jiang T, Mei Y, Zhu L, Zhou J, Deng Q. Predictors for recurrent ischemic stroke in patients with watershed infarct induced by intracranial artery stenosis. Clin Neurol Neurosurg. 2025 Jul;254:108897. doi: 10.1016/j.clineuro.2025.108897. Epub 2025 Apr 18.
- Derived from this study: PubMed 38902691Chen W, Zhang H, Li Z, Deng Q, Wang M, Chen Y, Zhang Y. Effects of edaravone dexborneol on functional outcome and inflammatory response in patients with acute ischemic stroke. BMC Neurol. 2024 Jun 20;24(1):209. doi: 10.1186/s12883-024-03712-1.
- Derived from this study: PubMed 34980176Sun H, Li S, Xu Z, Liu C, Gong P, Deng Q, Yan F. SNHG15 is a negative regulator of inflammation by mediating TRAF2 ubiquitination in stroke-induced immunosuppression. J Neuroinflammation. 2022 Jan 3;19(1):1. doi: 10.1186/s12974-021-02372-z.
- Derived from this study: PubMed 34511974Deng QW, Huang S, Li S, Zhai Q, Zhang Q, Wang ZJ, Chen WX, Sun H, Lu M, Zhou J. Inflammatory Factors as Potential Markers of Early Neurological Deterioration in Acute Ischemic Stroke Patients Receiving Endovascular Therapy - The AISRNA Study. J Inflamm Res. 2021 Sep 2;14:4399-4407. doi: 10.2147/JIR.S317147. eCollection 2021.
- Differential Long Noncoding RNA Expressions in Peripheral Blood Mononuclear Cells for Detection of Acute Ischemic StrokeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All information will be available to all researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junshan Zhou, Professor study chair
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke and Ischemic Stroke, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junshan Zhou, M.D. (+8602587726218, zhjsh333@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential expression pattern of circRNA/miRNA/lncRNA (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04175691, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.