Viral MyocarditisNCT03219996
Risk Factors for Predictors of In-hospital Death in Acute Fulminant Myocarditis
An observational study of Viral Myocarditis and Cardio-Renal Syndrome, run by The First Affiliated Hospital of Soochow University.
Trial summary
The investigators performed a retrospective, single-center observational study, and the participants with acute fulminant myocarditis were included.Then, the investigator analyzed the risk factors of in-hospital death in these participants with acute fulminant myocarditis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Myocarditis, Cardio-Renal Syndrome, Risk Factor, Cardiovascular
- What is being tested?
- prognosis
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The definition of a fulminant acute myocarditis was the presence of a rapid onset of aggressive life-threatening disease accompanied by cardiogenic shock with multiple organ dysfunction syndrome, acute severe heart failure, fatal arrhythmias, high-degree atrioventricular blockade, or sudden cardiac death following a flu-like illness.
Who may be able to join
- Clinical diagnosis of acute fulminant myocarditis
Who cannot join
- chronic renal dysfunction refuse medical treatments
About this study
Official title: Risk Factors Influenced Prognosis of Acute Fulminant Myocarditis by Analyzing Clinical Characteristics and Complications, Laboratory Findings, Treatments, and Electrocardiographic and Echocardiographic Data.
The investigators performed a retrospective, single-center observational study, and the participants with acute fulminant myocarditis were included.Then, the investigator analyzed the risk factors of in-hospital death in these participants with acute fulminant myocarditis.
- Being tested
- prognosis
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prognosisOther
The participants were divided into two groups based on survival at their hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| non-survivor group | Not described Receives: Other: prognosis | |
| survivor group | Not described Receives: Other: prognosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Impairment Influence Prognosis of Acute Fulminant Myocarditis
Measured: 2017-01-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Jan 2016
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral MyocarditisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangjun Yang, PhD, Principal investigator, First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219996
- Sponsor's protocol ID
- myocarditis20161226
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Influenced Prognosis of Acute Fulminant Myocarditis by Analyzing Clinical Characteristics and Complications, Laboratory Findings, Treatments, and Electrocardiographic and Echocardiographic Data.
- ClinicalTrials.gov ID
- NCT03219996
- Acronym / sponsor ID
- myocarditis20161226
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 18 Jul 2017 (actual)
- 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 investigators performed a retrospective, single-center observational study, and the participants with acute fulminant myocarditis were included.Then, the investigator analyzed the risk factors of in-hospital death in these participants with acute fulminant myocarditis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-survivor group | – | Other: prognosis |
| survivor group | – | Other: prognosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The definition of a fulminant acute myocarditis was the presence of a rapid onset of aggressive life-threatening disease accompanied by cardiogenic shock with multiple organ dysfunction syndrome, acute severe heart failure, fatal arrhythmias, high-degree atrioventricular blockade, or sudden cardiac death following a flu-like illness.
Key inclusion criteria (1 listed)
- Clinical diagnosis of acute fulminant myocarditis
Key exclusion criteria (1 listed)
- chronic renal dysfunction refuse medical treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prognosisThe participants were divided into two groups based on survival at their hospital discharge. | Other | non-survivor group, survivor group |
Primary outcome
Renal Impairment Influence Prognosis of Acute Fulminant Myocarditis
Time frame: 2017-01-30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- 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.
Xiangjun Yang, PhD principal investigator
First Affiliated Hospital of Soochow University
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Myocarditis and Cardio-Renal Syndrome, run by The First Affiliated Hospital of Soochow University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Impairment Influence Prognosis of Acute Fulminant Myocarditis (time frame: 2017-01-30). 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 Jul 2017.