Clinical trial NCT03170830: Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction
Official title: Study on CircRNA-Uck2 as a New Diagnostic Marker of Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Disease
Diagnoses Disease
Acute Myocardial Infarction
Lead sponsor: Beijing Haidian Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Fangshan District Liangxiang Hospital
First posted: 2017-05-31
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.

Primary outcomes:
measure: The change of cUck2 levels in AMI
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital
state: China/Beijing
Study officials:
affiliation: Beijing Haidian Hospital,Haidian Section of Peking University Third Hospital
name: Hong-Jin Wu
role: STUDY_DIRECTOR
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