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AzTrials

Cardiac DiseaseNCT03170830

Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction

A study testing the diagnosis value of cUck2 in acute myocardial infarction. in people with Cardiac Disease and Diagnoses Disease, run by Beijing Haidian Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
the diagnosis value of cUck2 in acute myocardial infarction.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteChina
Study dates
1 Aug 2015to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong-Yun Wang contact

+8618810252933

wanghongyun5491@163.com

Jing Li contact

+8618810551082

zhiyaguniang@sina.com

China1 site, 1 recruiting

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

    Beijing, China/Beijing, 100080

    Hong-Yun Wang, +8618810252933, wanghongyun5491@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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

Being tested
the diagnosis value of cUck2 in acute myocardial infarction.
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the diagnosis value of cUck2 in acute myocardial infarction.Diagnostic test

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

Study groups in NCT03170830
Study groupRoleWhat they receive
Healthy control groupExperimentalAge:45-75 years.Pepole who have normal ECG without the history of cardiovascular disease can be included in the healthy control group.
Receives: Diagnostic Test: the diagnosis value of cUck2 in acute myocardial infarction.
unstable angina disease control groupExperimentalAge:>18 years.Unstable angina patients meet the diagnostic criteria.
Receives: Diagnostic Test: the diagnosis value of cUck2 in acute myocardial infarction.
acute myocardial infarction groupExperimentalAge:>18 years.Acute myocardial infarction patients meet the diagnostic criteria.
Receives: Diagnostic Test: the diagnosis value of cUck2 in acute myocardial infarction.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2017
  2. Study start1 Aug 2015
  3. Primary completion31 Dec 2018 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03170830
Sponsor's protocol ID
KYZ2017001
Status last verified
May 2017
First submitted
19 May 2017
Last updated
31 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27294090

  • 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.

    PubMed 1069269

  • 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.

    PubMed 23249747

  • 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.

    PubMed 16682442

  • 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.

    PubMed 27539542

  • 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.

    PubMed 26802132

  • 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.

    PubMed 20886220

Questions about this trial

What is this clinical trial studying?

A study testing the diagnosis value of cUck2 in acute myocardial infarction. in people with Cardiac Disease and Diagnoses Disease, run by Beijing Haidian Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hong-Yun Wang (+8618810252933, wanghongyun5491@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of cUck2 levels 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03170830, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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