Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients With Coronary Artery Disease

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03635255
Collaborator
(none)
460
1
23.9
19.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Objective:To 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.

    Methods:The 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 Results:The 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    460 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients With Coronary Artery Disease
    Actual Study Start Date :
    Sep 24, 2019
    Anticipated Primary Completion Date :
    Aug 31, 2021
    Anticipated Study Completion Date :
    Sep 21, 2021

    Outcome Measures

    Primary Outcome Measures

    1. composite cardiovascular outcome [up to 10 years]

      Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. Male or female older than 20 years old.

    2. Have a history of cardiovascular disease (including coronary heart disease, or peripheral vascular disease)

    Exclusion Criteria:

    Significant valvular or congenital heart disease, cancer, immunosuppressive therapy, or other conditions or treatment your physician thinks you have

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NTUH Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Chau chung Wu, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03635255
    Other Study ID Numbers:
    • 201708063RIND
    First Posted:
    Aug 17, 2018
    Last Update Posted:
    Mar 16, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2021