Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Sepsis-induced Myocardial Injury

June 15, 2018 updated by: Bin He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for the patients of sepsis-induced myocardial injury at the emergency department (ED) and intensive care unit (ICU).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

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
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Ethics Committee of Xinhua 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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of sepsis-induced myocardial injury

Description

Inclusion Criteria:

  1. Diagnosis of sepsis:SOFA score increase >=2 at baseline level induced by infection.
  2. Suspected myocardial injury,including 1 as follows at least:Low blood pressure or using vasoactive drugs; ECG changes(ST segment changes or pathological Q wave); Troponin elevation(> 0.5 μg/L); BNP elevation(> 4670pg/ml); Echocardiography: cardiac function decline(EF<50%).

Exclusion Criteria:

  1. Skeletal muscle damage (induced by orthopedics, vascular surgery or trauma surgical disease, surgery);
  2. Pregnant and lactating women;
  3. Patients with mental disorders;
  4. Patients are using other experimental drugs;
  5. Refusal to provide informed consent

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Sepsis-induced myocardial injury group
Patients admitted to the hospital with the diagnosis of Sepsis-induced myocardial injury
Blank control group
Patients admitted to the hospital without the diagnosis of Sepsis-induced myocardial injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic value of microRNAs evaluate by qPCR in patients of sepsis-induced myocardial injury
Time Frame: Day 7
Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Prognostic value of microRNAs in patients of sepsis-induced myocardial injury
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

April 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 15, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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