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Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction

Primary Purpose

Cardiac Disease, Diagnoses Disease, Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the diagnosis value of cUck2 in acute myocardial infarction.
Sponsored by
Beijing Haidian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beijing Haidian Hospital, Haidian Section of Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy control group

unstable angina disease control group

acute myocardial infarction group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2017
Last Updated
May 26, 2017
Sponsor
Beijing Haidian Hospital
Collaborators
Beijing Fangshan District Liangxiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03170830
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Haidian Hospital
Collaborators
Beijing Fangshan District Liangxiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Diagnoses Disease, Acute Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Sample inspector
Allocation
Non-Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy control group
Arm Type
Experimental
Arm Description
Age:45-75 years.Pepole who have normal ECG without the history of cardiovascular disease can be included in the healthy control group.
Arm Title
unstable angina disease control group
Arm Type
Experimental
Arm Description
Age:>18 years.Unstable angina patients meet the diagnostic criteria.
Arm Title
acute myocardial infarction group
Arm Type
Experimental
Arm Description
Age:>18 years.Acute myocardial infarction patients meet the diagnostic criteria.
Intervention Type
Diagnostic Test
Intervention Name(s)
the diagnosis value of cUck2 in acute myocardial infarction.
Intervention Description
Collect blood at different time points and compare cUck2 in three groups.
Primary Outcome Measure Information:
Title
The change of cUck2 levels in AMI
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong-Yun Wang
Phone
+8618810252933
Email
wanghongyun5491@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Li
Phone
+8618810551082
Email
zhiyaguniang@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong-Jin Wu
Organizational Affiliation
Beijing Haidian Hospital,Haidian Section of Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital
City
Beijing
State/Province
China/Beijing
ZIP/Postal Code
100080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong-Yun Wang
Phone
+8618810252933
Email
wanghongyun5491@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27294090
Citation
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.
Results Reference
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PubMed Identifier
1069269
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. doi: 10.1073/pnas.73.11.3852.
Results Reference
background
PubMed Identifier
23249747
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.
Results Reference
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PubMed Identifier
16682442
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. doi: 10.1093/nar/gkl151.
Results Reference
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PubMed Identifier
27539542
Citation
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.
Results Reference
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PubMed Identifier
26802132
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.
Results Reference
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PubMed Identifier
20886220
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.
Results Reference
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Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction

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