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

NCT03635255 | Recruiting DMC

• 1 other identifier: 201708063RIND
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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

Conditions

miRNA

Keywords

CAD; miRNA

Outcome Measures

Primary Outcomes (1)

• composite cardiovascular outcome

  Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients

  up to 10 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• Male or female older than 20 years old.
• Have a history of cardiovascular disease (including coronary heart disease, or peripheral vascular disease)

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

NTUH

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: NONE RETAINED

Blood and Urine Sampling After enrollment, 20 mL of blood from peripheral vessels and 10 mL urine were collected. Sampling collection was at the time of enrollment, and every 3 months thereafter in 3-month intervals during outpatient clinic visits. These samples were stored in a -80°C refrigerator until analysis for biomarkers and metabolomic study. Patients were excluded if they had ingested any drugs with antioxidant activity, vitamins, or food additives within the 4 weeks prior to blood/urine sampling.

Study Officials

• Chau chung Wu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chau chung Wu, PhD

CONTACT

02-23123456; Chauchungwu@ntu.edu.tw

Mei chen Huang, Master

CONTACT

02-23123456; ntuh2015@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: September 24, 2019
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)