Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03635255
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2018-08-15
Brief Title:
Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients With Coronary Artery Disease
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients With Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary artery disease CAD resulting from atherosclerotic obstruction of epicardial coronary arteries accounts for more than one-third of deaths in subjects over the age of 35 worldwide The global incidence of CAD is on the rise owing to the international epidemic of obesity type 2 diabetes and aging all of which are potent risk factors for coronary atherosclerosis Participants with CAD are at high risk for subsequent adverse cardiovascular CV events and death it has been estimated that one out of every five CAD patients will experience at least one adverse CV event during a 5-year follow up period There is however no reliable diagnostic tool to predict the risk of adverse CV events or death in participanrs with CAD Increasing evidence suggests that miRNAs are stably present in serum plasma urine saliva and other body fluids and are considered a novel class of non-invasive biomarkers for various diseases including cancer neurodegenerative and cardiovascular diseases
Detailed Description:
ObjectiveTo identify the novel circulating miRNA expression profiles that may serve as a sensitive and reliable biomarker to predict future adverse CV outcomes and death in patients with established CAD
MethodsThe investigators propose to utilize next-generation sequencing RNASeq to identify the novel plasma miRNA expression signature linked to adverse CV outcomes in participanrs with CAD The identified miRNA candidates that are predictive of adverse CV events will be validated in a larger independent cohort of CAD patients In addition miRNAs that are linked to adverse CV outcomes in CAD patients will be investigated mechanistically in human aortic endothelial cells to understand their functional contribution to the occurrence of adverse CV events
What is New or Innovative in this Study This study could be one of the few studies to investigate circulating miRNAs as novel biomarkers for risk stratification and the clinical outcome prediction in patients with established CAD This report will also demonstrate that some dysregulated circulating miRNAs might contribute to endothelial dysfunction and adverse CV events in CAD patients
Scientific or Clinical Implication of the Expected ResultsThe results from this study will provide a new prognostic tool to predict CV outcomes in CAD patients using plasma miRNA expression signature It will also provide important scientific insights into the complex non-coding RNA regulatory network involved in the pathogenesis of atherosclerosis The insights from this study may provide a unique opportunity to improve the risk assessment of adverse CV events in CAD patients by targeting theses miRNAs
MethodsThe investigators propose to utilize next-generation sequencing RNASeq to identify the novel plasma miRNA expression signature linked to adverse CV outcomes in participanrs with CAD The identified miRNA candidates that are predictive of adverse CV events will be validated in a larger independent cohort of CAD patients In addition miRNAs that are linked to adverse CV outcomes in CAD patients will be investigated mechanistically in human aortic endothelial cells to understand their functional contribution to the occurrence of adverse CV events
What is New or Innovative in this Study This study could be one of the few studies to investigate circulating miRNAs as novel biomarkers for risk stratification and the clinical outcome prediction in patients with established CAD This report will also demonstrate that some dysregulated circulating miRNAs might contribute to endothelial dysfunction and adverse CV events in CAD patients
Scientific or Clinical Implication of the Expected ResultsThe results from this study will provide a new prognostic tool to predict CV outcomes in CAD patients using plasma miRNA expression signature It will also provide important scientific insights into the complex non-coding RNA regulatory network involved in the pathogenesis of atherosclerosis The insights from this study may provide a unique opportunity to improve the risk assessment of adverse CV events in CAD patients by targeting theses miRNAs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None