- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02755207
Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome
Study Overview
Status
Conditions
Detailed Description
The present study is a single-center, prospective diagnostic study among patients presenting to the ED or ICU within 24 h of onset of chest pain suggestive of suspected ACS.
We propose to construct the biobank of ACS and evaluate the potential diagnostic value of circulating microRNAs compared with cTnI for suspected ACS patients. All the patients are to be followed up for 6 months. Final diagnosis was made by an expert panel cardiologist, based on all available clinical information including cTnI measurements, ECG, coronary angiography, cardiac exercise tests and information from hospital discharge letters.
The concentrations of microRNAs will be evaluated by quantitative reverse transcription PCR, using highly specific primers and hybridization probes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200092
- Recruiting
- Ethics Committee of Xinhua Hospital
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Contact:
- Guangyu Chen, PhD
- Phone Number: +86-02125076143
- Email: xinhuacru@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Suspected ACS patients (STEMI, NSTEMI, and UA):
Age>18 years; Informed consent.
Exclusion Criteria:
Patients who will undergo immediate PCI; Pregnant and lactating women; Patients with mental disorders; Patients are using other experimental drugs; Refusal to provide informed.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Suspected ACS group
Patients admitted to the hospital with the diagnosis of ACS
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Blank control group
Patients admitted to the hospital without the diagnosis of ACS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the diagnostic value of microRNAs in qPCR,in ACS
Time Frame: Day 7
|
Day 7
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the prognostic value of microRNAs in ACS
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-16-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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