Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction

May 26, 2017 updated by: Hong-Jin Wu, Beijing Haidian Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • China/Beijing
      • Beijing, China/Beijing, China, 100080
        • Recruiting
        • Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: the diagnosis value of cUck2 in acute myocardial infarction.
Collect blood at different time points and compare cUck2 in three groups.
Experimental: unstable angina disease control group
Age:>18 years.Unstable angina patients meet the diagnostic criteria.
Diagnostic test: the diagnosis value of cUck2 in acute myocardial infarction.
Collect blood at different time points and compare cUck2 in three groups.
Experimental: acute myocardial infarction group
Age:>18 years.Acute myocardial infarction patients meet the diagnostic criteria.
Diagnostic test: the diagnosis value of cUck2 in acute myocardial infarction.
Collect blood at different time points and compare cUck2 in three groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Haidian Hospital

Collaborators

Beijing Fangshan District Liangxiang Hospital

Investigators

  • Study Director: Hong-Jin Wu, Beijing Haidian Hospital,Haidian Section of Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYZ2017001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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