Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Molecular Mechanisms of microRNA-494 Involving in Cerebral Ischemia

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: NCT03577093
Recruitment Status : Recruiting
First Posted : July 5, 2018
Last Update Posted : July 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Brief 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. 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.

Condition or disease Intervention/treatment
Ischemic Stroke Other: There is no intervention at all.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Molecular Mechanism of miR-494 Mediating Cell Cycle Regulation Following Cerebral Ischemia
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
ischemic stroke
acute ischemic stroke patients within 6h after stroke onset
Other: There is no intervention at all.
There is no intervention at all.

control
healthy controls
Other: There is no intervention at all.
There is no intervention at all.




Primary Outcome Measures :
  1. the molecular mechanism of miR-494 mediating cell cycle regulation following cerebral ischemia [ Time Frame: through study completion, an average of 2 years ]

Biospecimen Retention:   Samples With DNA
peripheral blood


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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
acute ischemic stroke patients who were presented within 6h of the event would be recruited to this study.
Criteria

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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.

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): NCT03577093


Contacts
Layout table for location contacts
Contact: Luo Yumin 01083198129 yumin111@ccmu.edu.cn

Locations
Layout table for location information
China
Xuanwu Hospital Recruiting
Beijing, China
Contact: Luo Yumin    01083198129    yumin111@ccmu.edu.cn   
Sponsors and Collaborators
Capital Medical University
Investigators
Layout table for investigator information
Principal Investigator: Luo Yumin Capital Medical University
Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Ji Xunming,MD,PhD, Vice President of Xuanwu Hospital,Capital Medical University, Capital Medical University
ClinicalTrials.gov Identifier: NCT03577093    
Other Study ID Numbers: miR-494
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data for all primary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by an external independent panel.Requestors will be required to sign a Data Access Agreement.
URL: http://bethesda.org

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 Ji Xunming,MD,PhD, Capital Medical University:
stroke, miR-494, neuroprotection, CDK
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Ischemia
Cerebral Infarction
Ischemia
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction