Evaluation of Plasma Non-coding RNAs as Biomarkers in Coronary Heart Disease

NCT02751060 | Enrolling By Invitation

• 1 other identifier: TJ-IRB20160305
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the expression level of miR-320a are effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of coronary heart disease.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• the plasma expression of miR-320a in coronary heart disease patients compared to control patients

  up to 24 months

Secondary Outcomes (5)

• number of participants with cardiovascular causes of death

  up to 24 months

• number of participants with non fatal myocardial infarction or stroke

  up to 24 months

• number of participants with re-hospitalization due to cardiovascular causes

  up to 24 months

• number of participants with all causes of mortality

  up to 24 months

• number of participants with myocardial infarction re-exacerbation or re-hospitalization

  up to 24 months

Study Arms (1)

patients with coronary heart disease symptoms

Other: No intervention

Interventions

No intervention OTHER

patients with coronary heart disease symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

4000 outpatients or hospitalized patients with coronary heart diseasewill be enrolled in this study.

You may qualify if:

• years of age or older;
• the most recent symptoms of coronary heart disease within 7 days;
• meet one of the following conditions: A. clinical history of typical ischemic chest pain (more than 5 minutes of persistent chest pain); B. serum cardiac biomarkers positive (TnT/I or creatine kinase peak greater than 99% of URL); C. Electrocardiogram changes of myocardial ischemia.

You may not qualify if:

• pregnant women or plan to;
• participate in any drug clinical trials within 3 months;
• patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
• serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
• previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
• patients refused to comply with the requirements of this study to complete the research work;
• according to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Dao Wen Wang, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 26, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CN (1)