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

NCT ID: NCT02835573

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Sepsis-induced Myocardial Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis-induced myocardial injury group

Patients admitted to the hospital with the diagnosis of Sepsis-induced myocardial injury

No interventions assigned to this group

Blank control group

Patients admitted to the hospital without the diagnosis of Sepsis-induced myocardial injury

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Bin He

M.D./Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ethics Committee of Xinhua Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Guangyu Chen, PhD

Role: primary

+86-02125076143

Other Identifiers

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XH-16-018

Identifier Type: -

Identifier Source: org_study_id

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