NCT03170830

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

3.4 years

First QC Date

May 19, 2017

Last Update Submit

May 26, 2017

Conditions

Cardiac DiseaseDiagnoses DiseaseAcute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (3)

Healthy control group

EXPERIMENTAL

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

Diagnostic Test: the diagnosis value of cUck2 in acute myocardial infarction.

unstable angina disease control group

EXPERIMENTAL

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

Diagnostic Test: the diagnosis value of cUck2 in acute myocardial infarction.

acute myocardial infarction group

EXPERIMENTAL

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

Diagnostic Test: the diagnosis value of cUck2 in acute myocardial infarction.

Interventions

the diagnosis value of cUck2 in acute myocardial infarction.DIAGNOSTIC_TEST

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

Healthy control groupacute myocardial infarction groupunstable angina disease control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital

Beijing, China/Beijing, 100080, China

RECRUITING

Related 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.

    PMID: 27294090BACKGROUND

  • 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.

    PMID: 1069269BACKGROUND

  • 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.

    PMID: 23249747BACKGROUND

  • 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.

    PMID: 16682442BACKGROUND

  • 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.

    PMID: 27539542BACKGROUND

  • 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.

    PMID: 26802132BACKGROUND

  • 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.

    PMID: 20886220BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Hong-Jin Wu

    Beijing Haidian Hospital,Haidian Section of Peking University Third Hospital

    STUDY DIRECTOR

Central Study Contacts

Hong-Yun Wang

CONTACT

+8618810252933wanghongyun5491@163.com

Jing Li

CONTACT

+8618810551082zhiyaguniang@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sample inspector
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 31, 2017

Study Start

August 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

CN(1)