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

Coronary Disease Clinical Trial

Official title:

Evaluation of Plasma Non-coding RNAs (miRNA-320a) as Biomarkers of Diagnosis, Prognosis and Treatment Effects in Coronary Heart Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02751060
• Other study ID #: TJ-IRB20160305
• Status: Enrolling by invitation
• Start date: April 2016
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4000
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the plasma expression of miR-320a in coronary heart disease patients compared to control patients		up to 24 months
Secondary	number of participants with cardiovascular causes of death		up to 24 months
Secondary	number of participants with non fatal myocardial infarction or stroke		up to 24 months
Secondary	number of participants with re-hospitalization due to cardiovascular causes		up to 24 months
Secondary	number of participants with all causes of mortality		up to 24 months
Secondary	number of participants with myocardial infarction re-exacerbation or re-hospitalization		up to 24 months