Sepsis-induced Myocardial InjuryNCT02835573
Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Sepsis-induced Myocardial Injury
An observational study of Sepsis-induced Myocardial Injury, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis-induced Myocardial Injury
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2018
- Phase
- Observational
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of sepsis-induced myocardial injury
Who may be able to join
- Diagnosis of sepsis:SOFA score increase >=2 at baseline level induced by infection.
- 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%).
Who cannot join
- Skeletal muscle damage (induced by orthopedics, vascular surgery or trauma surgical disease, surgery);
- Pregnant and lactating women;
- Patients with mental disorders;
- Patients are using other experimental drugs;
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Guangyu Chen, PhD, +86-02125076143, xinhuacru@163.com
About this study
Official title: 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).
- Conditions
- Sepsis-induced Myocardial Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of microRNAs evaluate by qPCR in patients of sepsis-induced myocardial injury
Measured: Day 7
Secondary outcomes (1)
Prognostic value of microRNAs in patients of sepsis-induced myocardial injury
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis-induced Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835573
- Sponsor's protocol ID
- XH-16-018
- Status last verified
- Jun 2018
- First submitted
- 11 Jul 2016
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- ClinicalTrials.gov ID
- NCT02835573
- Acronym / sponsor ID
- XH-16-018
- Conditions
- Sepsis-induced Myocardial Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of sepsis-induced myocardial injury
Key inclusion criteria (2 listed)
- Diagnosis of sepsis:SOFA score increase >=2 at baseline level induced by infection.
- 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%).
Key exclusion criteria (5 listed)
- Skeletal muscle damage (induced by orthopedics, vascular surgery or trauma surgical disease, surgery);
- Pregnant and lactating women;
- Patients with mental disorders;
- Patients are using other experimental drugs;
- Refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic value of microRNAs evaluate by qPCR in patients of sepsis-induced myocardial injury
Time frame: Day 7
1 secondary outcome
Prognostic value of microRNAs in patients of sepsis-induced myocardial injury
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis-induced Myocardial Injury, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 2 inclusion and 5 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 18 Jun 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of microRNAs evaluate by qPCR in patients of sepsis-induced myocardial injury (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2018.