Risk Factors for Predictors of In-hospital Death in Acute... | NCT03219996

Studies
Risk Factors for Predictors of In-hospital Death in Acute Fulminant Myocarditis

NCT03219996

Sponsor

The First Affiliated Hospital of Soochow University

Status

Completed

Last Update Posted

Jul 18, 2017Actual

Enrollment

76Actual

Phase

Not provided

Conditions

Viral Myocarditis
Cardio-Renal Syndrome
Risk Factor, Cardiovascular

Interventions

prognosis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 30, 2016Actual

Completion Date

Dec 30, 2016Actual

First Submitted Date

Jul 4, 2017

First Submission Date that Met QC Criteria

Jul 14, 2017

First Posted Date

Jul 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2017

Last Update Posted Date

Jul 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-survivor group			Other: prognosis
survivor group			Other: prognosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prognosis	Other	The participants were divided into two groups based on survival at their hospital discharge.	non-survivor group survivor group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal Impairment Influence Prognosis of Acute Fulminant Myocarditis		2017-01-30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of acute fulminant myocarditis

Exclusion Criteria:

chronic renal dysfunction refuse medical treatments

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiangjun Yang, PhD	First Affiliated Hospital of Soochow University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059347	Cardio-Renal Syndrome

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided