Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction

Not Applicable

• Conditions: Cardiac Disease; Acute Myocardial Infarction; Diagnoses Disease
• Interventions: Diagnostic Test: the diagnosis value of cUck2 in acute myocardial infarction.

• Registration Number: NCT03170830
• Lead Sponsor: Beijing Haidian Hospital

Brief Summary

This is an observational diagnostic study that aims to evaluate the diagnostic value of circRNA-Uck2 in Acute Myocardial Infarction (AMI) in adults as compared to healthy and unstable angina controls. Rapid and adequate diagnosis of AMI is of great importance to enable a rapid start of treatment, save large tracts of dying myocardium, reduce the infarct size,and thereby decrease the risk of subsequent heart failure.

Detailed Description

RATIONAL acute myocardial infarction (AMI) is the leading cause of sudden death and heart failure worldwide. And about 10% of all emergency department consultations are with symptoms suggestive of AMI, however, only 10% to 20% of them are diagnosed as experiencing an AMI. Rapid and accurate identification of AMI is of paramount clinical importance for subsequent timely and effectively treatment and management.

Recently, the investigators identified microarray analysis and real-time polymerase chain reaction (PCR) from AMI animal models and small samples of AMI patients, a molecular signature of AMI involving 5 circRNAs (circRNA_006877, circRNA_015350, circRNA_002969, circRNA_013240, circRNA_004682) was found significantly change in AMI patients and likely serves as candidate serum biomarkers of AMI. Among the 5 circRNAs, circRNA_006877 name of circRNA-Uck2 (cUck2) has more close association with AMI.

TYPE OF STUDY : multicenter diagnostic evaluation Study MAIN PURPOSE OF THE STUDY : To evaluate the diagnostic value of circRNAs in AMI in adults as compared to healthy and unstable angina controls

SECONDARY OBJECTIVES :

assess the ability of cUck2 to discriminate a AMI disease from unstable angina patients in adults.

explore the relationship between cUck2 and heart function after myocardial infarction PRODUCTS OF THE STUDY diagnostic kit of AMI in quantitative polymerase chain reaction (qPCR) NUMBER OF PATIENTS : 3 groups with 169 patients will be included Group 1: 66 AMI adult patients Group 2: 56 unstable angina adults Group 3: 56 Witnesses healthy adults INCLUSION LENGTH 36 months DURATION OF THE STUDY 42 months

Study Timeline

• Study Start: 2015-08-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-26
• Last Update Submitted: 2017-05-26
• Study First Posted: 2017-05-31
• Last Update Posted: 2017-05-31
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Health Control Group:Pepole who have normal ECG, deny the history of cardiovascular disease can be included in the healthy control group.
• Acute Myocardial Infarction Group:Clinical diagnosis of acute myocardial infarction
• Unstable Angina Group:Clinical diagnosis of unstable angina.
• Sign informed consent.

Exclusion Criteria

• Myocarditis, hypertrophic cardiomyopathy, ablation.
• Malignant hypertension, severe arrhythmia.
• Chronic muscle disorders, rhabdomyolysis.
• Severe liver and kidney dysfunction.
• Malignant tumors, acute cerebrovascular disease.
• Severe neurosis, psychosis.
• Patients who had any of the above were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy control group	the diagnosis value of cUck2 in acute myocardial infarction.	Age:45-75 years.Pepole who have normal ECG without the history of cardiovascular disease can be included in the healthy control group.
unstable angina disease control group	the diagnosis value of cUck2 in acute myocardial infarction.	Age:\>18 years.Unstable angina patients meet the diagnostic criteria.
acute myocardial infarction group	the diagnosis value of cUck2 in acute myocardial infarction.	Age:\>18 years.Acute myocardial infarction patients meet the diagnostic criteria.

Primary Outcome Measures

Name	Time	Method
The change of cUck2 levels in AMI	It is totally 7 time points to detect cUck2, including the moment of admission, and the 1st day、the 2nd day、the 3th day、the 7th day、the 14th day、the 6th month after admission in AMI patients.	The investigators has found cUck2 has more close association with AMI.Detect cUck2 levels in different time points and it will give more information about its diagnostic value in AMI.

Trial Locations

Locations (1)

Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital; 🇨🇳 Beijing, China/Beijing, China