miRNANCT03635255
Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients With Coronary Artery Disease
An observational study of miRNA, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- miRNA
- How many people
- 460 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Sep 2019to 31 Jul 2027
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: 1. Male or female older than 20 years old. 2. Have a history of cardiovascular disease (including coronary heart disease, or peripheral vascular disease)
Who may be able to join
- Male or female older than 20 years old.
- Have a history of cardiovascular disease (including coronary heart disease, or peripheral vascular disease)
Who cannot join
- Significant valvular or congenital heart disease, cancer, immunosuppressive therapy, or other conditions or treatment your physician thinks you have
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei
Chau chuna Wu, 886-2-23123456 ext. 88560, chauchungwu@ntu.edu.tw
MeiChen Huang, 886-2-23123456 ext. 88559, ntuh2015@gmail.com
About this study
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
Read the 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.
- Conditions
- miRNA
- Keywords
- CAD, miRNA
What is being measured
The primary outcome is the main question the study is designed to answer.
composite cardiovascular outcome
Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start24 Sep 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for miRNAStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chau chung Wu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635255
- Sponsor's protocol ID
- 201708063RIND
- Status last verified
- Jun 2025
- First submitted
- 15 Aug 2018
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03635255
- Acronym / sponsor ID
- 201708063RIND
- Conditions
- miRNA
- Keywords
- CAD, miRNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Aug 2018 (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.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Male or female older than 20 years old. 2. Have a history of cardiovascular disease (including coronary heart disease, or peripheral vascular disease)
Key inclusion criteria (2 listed)
- Male or female older than 20 years old.
- Have a history of cardiovascular disease (including coronary heart disease, or peripheral vascular disease)
Key exclusion criteria (1 listed)
- Significant valvular or congenital heart disease, cancer, immunosuppressive therapy, or other conditions or treatment your physician thinks you have
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite cardiovascular outcome
Time frame: up to 10 years
Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients
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 17 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Chau chung Wu, PhD principal investigator
National Taiwan University Hospital
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 miRNA, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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 17 Jul 2025. 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 Taiwan. 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 Chau chung Wu, PhD (02-23123456 ext. 88560, Chauchungwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite cardiovascular outcome (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.