Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

Study on CircRNA-Uck2 as a New Diagnostic Marker of Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03170830
• Other study ID #: KYZ2017001
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2017
• Last updated: May 26, 2017
• Start date: August 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2017
• Source: Beijing Haidian Hospital
• Contact: Hong-Yun Wang
• Phone: +8618810252933
• Email: wanghongyun5491[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiac Disease
• Diagnoses Disease
• Heart Diseases
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• the diagnosis value of cUck2 in acute myocardial infarction.
Collect blood at different time points and compare cUck2 in three groups.

Locations

Country	Name	City	State
China	Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital	Beijing	China/Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Haidian Hospital	Beijing Fangshan District Liangxiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Danese E, Montagnana M. An historical approach to the diagnostic biomarkers of acute coronary syndrome. Ann Transl Med. 2016 May;4(10):194. doi: 10.21037/atm.2016.05.19. Review. — View Citation

Holdt LM, Stahringer A, Sass K, Pichler G, Kulak NA, Wilfert W, Kohlmaier A, Herbst A, Northoff BH, Nicolaou A, Gäbel G, Beutner F, Scholz M, Thiery J, Musunuru K, Krohn K, Mann M, Teupser D. Circular non-coding RNA ANRIL modulates ribosomal RNA maturation and atherosclerosis in humans. Nat Commun. 2016 Aug 19;7:12429. doi: 10.1038/ncomms12429. — View Citation

Jeck WR, Sorrentino JA, Wang K, Slevin MK, Burd CE, Liu J, Marzluff WF, Sharpless NE. Circular RNAs are abundant, conserved, and associated with ALU repeats. RNA. 2013 Feb;19(2):141-57. doi: 10.1261/rna.035667.112. Epub 2012 Dec 18. Erratum in: RNA. 2013 Mar;19(3):426. — View Citation

Meder B, Keller A, Vogel B, Haas J, Sedaghat-Hamedani F, Kayvanpour E, Just S, Borries A, Rudloff J, Leidinger P, Meese E, Katus HA, Rottbauer W. MicroRNA signatures in total peripheral blood as novel biomarkers for acute myocardial infarction. Basic Res Cardiol. 2011 Jan;106(1):13-23. doi: 10.1007/s00395-010-0123-2. Epub 2010 Oct 1. — View Citation

Sanger HL, Klotz G, Riesner D, Gross HJ, Kleinschmidt AK. Viroids are single-stranded covalently closed circular RNA molecules existing as highly base-paired rod-like structures. Proc Natl Acad Sci U S A. 1976 Nov;73(11):3852-6. — View Citation

Suzuki H, Zuo Y, Wang J, Zhang MQ, Malhotra A, Mayeda A. Characterization of RNase R-digested cellular RNA source that consists of lariat and circular RNAs from pre-mRNA splicing. Nucleic Acids Res. 2006 May 8;34(8):e63. — View Citation

Wang K, Long B, Liu F, Wang JX, Liu CY, Zhao B, Zhou LY, Sun T, Wang M, Yu T, Gong Y, Liu J, Dong YH, Li N, Li PF. A circular RNA protects the heart from pathological hypertrophy and heart failure by targeting miR-223. Eur Heart J. 2016 Sep 1;37(33):2602-11. doi: 10.1093/eurheartj/ehv713. Epub 2016 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of cUck2 levels in AMI	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.	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.