- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03219996
Risk Factors for Predictors of In-hospital Death in Acute Fulminant Myocarditis
July 14, 2017 updated by: The First Affiliated Hospital of Soochow University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
76
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
Clinical diagnosis of acute fulminant myocarditis
Exclusion Criteria:
chronic renal dysfunction refuse medical treatments
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
non-survivor group
|
The participants were divided into two groups based on survival at their hospital discharge.
|
survivor group
|
The participants were divided into two groups based on survival at their hospital discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Renal Impairment Influence Prognosis of Acute Fulminant Myocarditis
Time Frame: 2017-01-30
|
2017-01-30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiangjun Yang, PhD, First Affiliated Hospital of Soochow University
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)
January 1, 2016
Primary Completion (Actual)
December 30, 2016
Study Completion (Actual)
December 30, 2016
Study Registration Dates
First Submitted
July 4, 2017
First Submitted That Met QC Criteria
July 14, 2017
First Posted (Actual)
July 18, 2017
Study Record Updates
Last Update Posted (Actual)
July 18, 2017
Last Update Submitted That Met QC Criteria
July 14, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- myocarditis20161226
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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