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

• Sponsor: Tongji Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT02751060
• Collaborator: (none)
• Enrollment: 4,000
• Location: 1
• Anticipated Duration (Months): 80
• Patients Per Site Per Month: 50

Study Details

Study Description

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	Phase
Coronary Disease	Other: No intervention

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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: Apr 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the plasma expression of miR-320a in coronary heart disease patients compared to control patients [up to 24 months]

Secondary Outcome Measures

1. number of participants with cardiovascular causes of death [up to 24 months]

2. number of participants with non fatal myocardial infarction or stroke [up to 24 months]

3. number of participants with re-hospitalization due to cardiovascular causes [up to 24 months]

4. number of participants with all causes of mortality [up to 24 months]

5. number of participants with myocardial infarction re-exacerbation or re-hospitalization [up to 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital	Wuhan	Hubei	China	430030

Sponsors and Collaborators

• Tongji Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dao Wen Wang, Prof., Tongji Hospital
• ClinicalTrials.gov Identifier: NCT02751060
• Other Study ID Numbers: TJ-IRB20160305
• First Posted: Apr 26, 2016
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia

Study Results

No Results Posted as of Apr 1, 2021