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

April 9, 2024 updated by: Dao Wen Wang, Tongji Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with coronary heart disease symptoms
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the plasma expression of miR-320a in coronary heart disease patients compared to control patients
Time Frame: up to 24 months
up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
number of participants with cardiovascular causes of death
Time Frame: up to 24 months
up to 24 months
number of participants with non fatal myocardial infarction or stroke
Time Frame: up to 24 months
up to 24 months
number of participants with re-hospitalization due to cardiovascular causes
Time Frame: up to 24 months
up to 24 months
number of participants with all causes of mortality
Time Frame: up to 24 months
up to 24 months
number of participants with myocardial infarction re-exacerbation or re-hospitalization
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Principal Investigator: Dao Wen Wang, Doctor, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimated)

April 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20160305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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