Overview

This trial is active, not recruiting.

Condition acute coronary syndrome
Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Start date April 2016
End date December 2018
Trial size 100 participants
Trial identifier NCT02755207, XH-16-003

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients admitted to the hospital with the diagnosis of ACS
Patients admitted to the hospital without the diagnosis of ACS

Primary Outcomes

Measure
Evaluate the diagnostic value of microRNAs in qPCR,in ACS
time frame: Day 7

Secondary Outcomes

Measure
Evaluate the prognostic value of microRNAs in ACS
time frame: 6 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Suspected ACS patients (STEMI, NSTEMI, and UA): Symptoms: Chest pain; angina pectoris; radiation pain; ECG: ST segment elevation or depression > 0.1 mV in at least 2 contiguous electrocardiographic leads or Pathological Q wave occurs; Cardiac ultrasound: Decreased cardiac function; History of coronary heart disease; 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.

Additional Information

Official title Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.