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NCT02755207 Clinical Trial

Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:
Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02755207
Other study ID # XH-16-003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2016
Est. completion date December 2020

Study information
Verified date April 2019
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact bin he
Email hebinicu@139.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for suspected ACS patients at the emergency department (ED) and intensive care unit (ICU).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2020
Est. primary completion date May 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Ethics Committee of Xinhua Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the diagnostic value of microRNAs in qPCR,in ACS Day 7
Secondary Evaluate the prognostic value of microRNAs in ACS 6 months
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