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Enrolling by Invitation

NCT Number: NCT02751060

Evaluation of Plasma Non-coding RNAs as Biomarkers 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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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.

Exclusion criteria

  • 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).

Treatment and study plan

No intervention

Other

Primary outcomes

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

    Time frame: up to 24 months

Secondary outcomes

  1. number of participants with cardiovascular causes of death

    Time frame: up to 24 months

  2. number of participants with non fatal myocardial infarction or stroke

    Time frame: up to 24 months

  3. number of participants with re-hospitalization due to cardiovascular causes

    Time frame: up to 24 months

  4. number of participants with all causes of mortality

    Time frame: up to 24 months

  5. number of participants with myocardial infarction re-exacerbation or re-hospitalization

    Time frame: up to 24 months

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Apr 26, 2016
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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