Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction

NCT ID: NCT03170830

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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

Conditions

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Cardiac Disease Diagnoses Disease Acute Myocardial Infarction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants
Sample inspector

Study Groups

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Healthy control group

Age:45-75 years.Pepole who have normal ECG without the history of cardiovascular disease can be included in the healthy control group.

Group Type EXPERIMENTAL

the diagnosis value of cUck2 in acute myocardial infarction.

Intervention Type DIAGNOSTIC_TEST

Collect blood at different time points and compare cUck2 in three groups.

unstable angina disease control group

Age:\>18 years.Unstable angina patients meet the diagnostic criteria.

Group Type EXPERIMENTAL

the diagnosis value of cUck2 in acute myocardial infarction.

Intervention Type DIAGNOSTIC_TEST

Collect blood at different time points and compare cUck2 in three groups.

acute myocardial infarction group

Age:\>18 years.Acute myocardial infarction patients meet the diagnostic criteria.

Group Type EXPERIMENTAL

the diagnosis value of cUck2 in acute myocardial infarction.

Intervention Type DIAGNOSTIC_TEST

Collect blood at different time points and compare cUck2 in three groups.

Interventions

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the diagnosis value of cUck2 in acute myocardial infarction.

Collect blood at different time points and compare cUck2 in three groups.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Fangshan District Liangxiang Hospital

OTHER

Sponsor Role collaborator

Beijing Haidian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hong-Jin Wu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong-Jin Wu

Role: STUDY_DIRECTOR

Beijing Haidian Hospital,Haidian Section of Peking University Third Hospital

Locations

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Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital

Beijing, China/Beijing, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong-Yun Wang

Role: CONTACT

Phone: +8618810252933

Email: [email protected]

Jing Li

Role: CONTACT

Phone: +8618810551082

Email: [email protected]

Facility Contacts

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Hong-Yun Wang

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27294090 (View on PubMed)

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. doi: 10.1073/pnas.73.11.3852.

Reference Type BACKGROUND
PMID: 1069269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23249747 (View on PubMed)

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. doi: 10.1093/nar/gkl151.

Reference Type BACKGROUND
PMID: 16682442 (View on PubMed)

Holdt LM, Stahringer A, Sass K, Pichler G, Kulak NA, Wilfert W, Kohlmaier A, Herbst A, Northoff BH, Nicolaou A, Gabel 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.

Reference Type BACKGROUND
PMID: 27539542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26802132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20886220 (View on PubMed)

Other Identifiers

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KYZ2017001

Identifier Type: -

Identifier Source: org_study_id