Circulating Non-coding RNAs and Cardiovascular Outcomes in Patients With Dyslipidemia and Atherosclerosis

NCT03279770 | Unknown DMC

• 1 other identifier: 201505165RINC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular diseases and stroke are the major causes of morbidity and death in Taiwan. There is a clear need to identify novel mediators of atherosclerosis in dyslipidemic patients to provide insights into the pathogenesis, to tailor clinical care based on cardiovascular risks, and to develop new therapeutic strategies. While the roles of lncRNAs in human diseases including cancer and neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation contributes to atherosclerotic vascular diseases in patients with dyslipidemia. In this proposal, we seek to apply next-generation sequencing technology to investigate circulating (plasma and peripheral blood mononuclear cells \[PBMC\]) lncRNA expression in control subjects and in dyslipidemic patients with and without atherosclerotic vascular diseases (CAD, ischemic stroke and PAOD). The results from these experiments will lead to better understanding of how circulating lncRNAs contribute to atherosclerotic cardiovascular complications.

Conditions

Cardiovascular Diseases

Keywords

lnRNA; CV disease

Outcome Measures

Primary Outcomes (1)

• Composite cardiovascular outcome

  The composite cardiovascular (CV) outcome will be any CV events (coronary, cerebral, or peripheral vascular diseases)

  up to 5 years

Eligibility Criteria

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

Study Population

patients with dyslipidemia, atherosclerotic vascular diseases, or at least one CV risk factors

You may qualify if:

• Dyslipidemia: Total cholesterol (TC) \>200 mg/dL; LDL-C \> 130 mg/dL ; TG \> 200 mg/dL; male HDL-C \< 40 mg/dL, female HDL-C \< 50 mg/dL, or under lipid lowering therapy
• Atherosclerotic vascular disease:
• Coronary atherosclerosis as evidenced by cardiac catheterization examination, having history of myocardial infarction as evidenced by ECG or hospitalization, angina patient showing ischemic ECG changes or positive response to stress test;
• Cerebral vascular disease, cerebral infarction, intracerebral hemorrhage (excluding intracerebral hemorrhage associated with other diseases); transient ischemic attack (TIA) with carotid artery ultrasound confirming atheromatous change with more than 70% blockage;
• Peripheral atherosclerosis with symptoms of ischemia and confirmed by Doppler ultrasound or angiography in history.
• Control subjects: Age, gender-matched healthy adults without dyslipidemia and atherosclerotic diseases will be recruited as control subjects.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum Non-coding RNAs

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Chau-Chung Wu, M.D., Ph. D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chau-Chung Wu, M.D.,Ph.D.

CONTACT

02-23123456; chauchungwu@ntu.edu.tw

Peo-Chun Cheng, BS

CONTACT

02-23123456; ntuh204@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: September 12, 2017
• Study Start: June 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)