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Ischemic StrokeNCT03577093

Molecular Mechanisms of microRNA-494 Involving in Cerebral Ischemia

An observational study of Ischemic Stroke, run by Capital Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We and other investigations suggested that the activation of nerve cell cycle following cerebral ischemia led to neuronal apoptosis, glial cell proliferation and the formation of glial scar.The cyclin-dependent kinases (CDKs) and cyclins jointly promoted the cell cycle progression. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke
How many people
600 participants
Where
1 siteChina
Study dates
6 Jun 2018to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • Adult, Older adult

Study population: acute ischemic stroke patients who were presented within 6h of the event would be recruited to this study.

Who may be able to join

  • (1）diagnosis of first ischemic stroke based on clinical information and magnetic resonance imaging; (2)presentation of subjects within 6h of the event; (3)National Institutes of Health Stroke Scale (NIHSS) score between 4 and 15.

Who cannot join

  • (1）suspected cardiogenic embolism;(2）secondary stroke from cerebral hemorrhage, trauma, cancer or aneurysm and so on;(3）bleeding tendency;(4）severe cardiac,pulmonary,hepatic or renal insufficiency;(5）Vital signs are unstable to be assessed.

Trial locations and contacts

1 site in 1 country.

Luo Yumin contact

01083198129

yumin111@ccmu.edu.cn

China1 site, 1 recruiting

  • Xuanwu Hospital

    Beijing

    Luo Yumin, 01083198129, yumin111@ccmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Study on the Molecular Mechanism of miR-494 Mediating Cell Cycle Regulation Following Cerebral Ischemia

We and other investigations suggested that the activation of nerve cell cycle following cerebral ischemia led to neuronal apoptosis, glial cell proliferation and the formation of glial scar.The cyclin-dependent kinases (CDKs) and cyclins jointly promoted the cell cycle progression. Our preliminary clinical trial found a new microRNA-miR-494, which involved in the occurrence of acute ischemic stroke. In our animal experiment, miR-494 could relieve cerebral ischemia injury through inhibiting cyclin-dependent kinase 6(CDK6), ubiquitin-conjugating enzyme E2L6 (UBE2L6) and histone deacetylase 3 (HDAC3), which suggested that miR-494 might play an important role in the regulation of cell cycle following cerebral ischemia. This project intends to verify the following hypothesis：①miR-494 suppresses CDK6, and/or fibroblast growth factor16(FGF16)-Ras-extracellular signal-regulated kinase(ERK)--v-myc avian myelocytomatosis viral oncogene homolog(MYC) pathway, and/or phosphatase and tensin homolog(PTEN)-/protein kinase B(AKT)-mechanistic target of rapamycin(mTOR)-S6k pathway;②miR-494 inhibits UBE2L6, upregulates the hypoxia-inducible factor 1 α(HIF-1α) expression in nerve cells, thereby increases the p21 and p27 protein levels and inhibits cyclin-dependent kinase2(CDK2)activity;③miR-494 represses HDAC3 and downregulates the cyclin-dependent kinase1(CDK1)protein level. These all mediate the cell cycle arrest of neurons and astrocytes, reduce the neuronal apoptosis and glial scar formation,promote the recovery of neurological function and provide new targets for the treatment of ischemic stroke.

Conditions
Ischemic Stroke
Being tested
There is no intervention at all.
Keywords
stroke, miR-494, neuroprotection, CDK
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • There is no intervention at all.Other

    There is no intervention at all.

Study groups in NCT03577093
Study groupRoleWhat they receive
ischemic strokeacute ischemic stroke patients within 6h after stroke onset
Receives: Other: There is no intervention at all.
controlhealthy controls
Receives: Other: There is no intervention at all.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the molecular mechanism of miR-494 mediating cell cycle regulation following cerebral ischemia

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2018
  2. Study start6 Jun 2018
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03577093
Sponsor's protocol ID
miR-494
Status last verified
Jul 2018
First submitted
22 Jun 2018
Last updated
5 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data for all primary outcome measures will be made available.

Publications

  • Bizen N, Inoue T, Shimizu T, Tabu K, Kagawa T, Taga T. A growth-promoting signaling component cyclin D1 in neural stem cells has antiastrogliogenic function to execute self-renewal. Stem Cells. 2014 Jun;32(6):1602-15. doi: 10.1002/stem.1613.

    PubMed 24302516

  • Zhao H, Wang J, Gao L, Wang R, Liu X, Gao Z, Tao Z, Xu C, Song J, Ji X, Luo Y. MiRNA-424 protects against permanent focal cerebral ischemia injury in mice involving suppressing microglia activation. Stroke. 2013 Jun;44(6):1706-13. doi: 10.1161/STROKEAHA.111.000504. Epub 2013 Apr 23.

    PubMed 23613494

  • Iyirhiaro GO, Zhang Y, Estey C, O'Hare MJ, Safarpour F, Parsanejad M, Wang S, Abdel-Messih E, Callaghan SM, During MJ, Slack RS, Park DS. Regulation of ischemic neuronal death by E2F4-p130 protein complexes. J Biol Chem. 2014 Jun 27;289(26):18202-13. doi: 10.1074/jbc.M114.574145. Epub 2014 May 14.

    PubMed 24828495

  • Nobs L, Baranek C, Nestel S, Kulik A, Kapfhammer J, Nitsch C, Atanasoski S. Stage-specific requirement for cyclin D1 in glial progenitor cells of the cerebral cortex. Glia. 2014 May;62(5):829-39. doi: 10.1002/glia.22646. Epub 2014 Feb 19.

    PubMed 24550001

  • Demyanenko S, Uzdensky A. Profiling of Signaling Proteins in Penumbra After Focal Photothrombotic Infarct in the Rat Brain Cortex. Mol Neurobiol. 2017 Nov;54(9):6839-6856. doi: 10.1007/s12035-016-0191-x. Epub 2016 Oct 22.

    PubMed 27771897

  • Zhao H, Luo Y, Liu X, Wang R, Yan F, Liu X, Li S, Leak RK, Ji X. Ischemic post-conditioning partially reverses cell cycle reactivity following ischemia/reperfusion injury: a genome-wide survey. CNS Neurol Disord Drug Targets. 2013 May 1;12(3):350-9. doi: 10.2174/1871527311312030008.

    PubMed 23469856

  • Liu L, Lu Y, Martinez J, Bi Y, Lian G, Wang T, Milasta S, Wang J, Yang M, Liu G, Green DR, Wang R. Proinflammatory signal suppresses proliferation and shifts macrophage metabolism from Myc-dependent to HIF1alpha-dependent. Proc Natl Acad Sci U S A. 2016 Feb 9;113(6):1564-9. doi: 10.1073/pnas.1518000113. Epub 2016 Jan 25.

    PubMed 26811453

  • Fournier M, Orpinell M, Grauffel C, Scheer E, Garnier JM, Ye T, Chavant V, Joint M, Esashi F, Dejaegere A, Gonczy P, Tora L. KAT2A/KAT2B-targeted acetylome reveals a role for PLK4 acetylation in preventing centrosome amplification. Nat Commun. 2016 Oct 31;7:13227. doi: 10.1038/ncomms13227.

    PubMed 27796307

  • Jiang Y, Hsieh J. HDAC3 controls gap 2/mitosis progression in adult neural stem/progenitor cells by regulating CDK1 levels. Proc Natl Acad Sci U S A. 2014 Sep 16;111(37):13541-6. doi: 10.1073/pnas.1411939111. Epub 2014 Aug 26.

    PubMed 25161285

  • Li G, Ma X, Zhao H, Fan J, Liu T, Luo Y, Guo Y. Long non-coding RNA H19 promotes leukocyte inflammation in ischemic stroke by targeting the miR-29b/C1QTNF6 axis. CNS Neurosci Ther. 2022 Jun;28(6):953-963. doi: 10.1111/cns.13829. Epub 2022 Mar 24.

    PubMed 35322553

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Capital 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 1 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: status not confirmed, as of the sponsor's last update on 5 Jul 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luo Yumin (01083198129, yumin111@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the molecular mechanism of miR-494 mediating cell cycle regulation following cerebral ischemia (time frame: through study completion, an average of 2 years). 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 NCT03577093, which also lists 10 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 5 Jul 2018.

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