NCT03219996

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

12 months

First QC Date

July 4, 2017

Last Update Submit

July 14, 2017

Conditions

Viral MyocarditisCardio-Renal SyndromeRisk Factor, Cardiovascular

Outcome Measures

Primary Outcomes (1)

  • Renal Impairment Influence Prognosis of Acute Fulminant Myocarditis

    2017-01-30

Study Arms (2)

non-survivor group

Other: prognosis

survivor group

Other: prognosis

Interventions

prognosisOTHER

The participants were divided into two groups based on survival at their hospital discharge.

non-survivor groupsurvivor group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Clinical diagnosis of acute fulminant myocarditis

You may not qualify if:

  • chronic renal dysfunction refuse medical treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Xiangjun Yang, PhD

    First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 18, 2017

Study Start

January 1, 2016

Primary Completion

December 30, 2016

Study Completion

December 30, 2016

Last Updated

July 18, 2017

Record last verified: 2017-07