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

• Conditions: Coronary Disease
• Interventions: Other: No intervention

• Registration Number: NCT02751060
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

1. 18 years of age or older;
2. the most recent symptoms of coronary heart disease within 7 days;
3. 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.

Exclusion Criteria

1. pregnant women or plan to;
2. participate in any drug clinical trials within 3 months;
3. patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
4. serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
5. 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);
6. patients refused to comply with the requirements of this study to complete the research work;
7. 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with coronary heart disease symptoms	No intervention	-

Primary Outcome Measures

Name	Time	Method
the plasma expression of miR-320a in coronary heart disease patients compared to control patients	up to 24 months

Secondary Outcome Measures

Name	Time	Method
number of participants with cardiovascular causes of death	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 non fatal myocardial infarction or stroke	up to 24 months
number of participants with myocardial infarction re-exacerbation or re-hospitalization	up to 24 months

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China