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

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ClinicalTrials.gov Identifier: NCT02751060
Recruitment Status : Enrolling by invitation
First Posted : April 26, 2016
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Dao Wen Wang, 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.

Condition or disease Intervention/treatment
Coronary Disease Other: No intervention

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Evaluation of Plasma Non-coding RNAs (miRNA-320a) as Biomarkers of Diagnosis, Prognosis and Treatment Effects in Coronary Heart Disease
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. the plasma expression of miR-320a in coronary heart disease patients compared to control patients [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751060


Locations
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China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Tongji Hospital
Investigators
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Principal Investigator: Dao Wen Wang, Doctor Tongji Hospital

Additional Information:

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Responsible Party: Dao Wen Wang, Prof., Tongji Hospital
ClinicalTrials.gov Identifier: NCT02751060     History of Changes
Other Study ID Numbers: TJ-IRB20160305
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases