NCT04977518

Brief Summary

This was a retrospective observational study of consecutive cases of definite or possible infective endocarditis (IE) as per the modified Duke criteria between January 2008 and December 2015, which was performed at the Second Affiliated Hospital of Zhejiang University, School of medicine (SAHZU), a tertiary care referral hospital located in East China.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 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, 2008

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2016

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
Last Updated

July 27, 2021

Status Verified

March 1, 2016

Enrollment Period

8 years

First QC Date

July 13, 2021

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Complications (neurological events, systemic embolism, and congestive heart failure) of infective endocarditis

    1. A neurological event was defined as symptomatic or asymptomatic stroke, hemorrhage, or encephalopathy. 2. Systemic embolization was defined as an embolic event outside of the central nervous system. 3. Congestive heart failure was defined as with class III, or IV heart failure and an ejection fraction of 40% or less.

    During the hospitalization, average of 1 months

  • Mortality

    Patients dead or moribund before discharge

    During the hospitalization, average of 1 months

Study Arms (2)

Patients diagnosed during 2008-2011

Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2008-2011

Other: no intervention

Patients diagnosed during 2012-2015

Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2012-2015

Other: no intervention

Interventions

no intervention

Patients diagnosed during 2008-2011Patients diagnosed during 2012-2015

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a clinical diagnosis of infective endocarditis between January 2008 and December 2015 in a tertiary hospital located in the East China

You may qualify if:

  • Patients with a clinical diagnosis of infective endocarditis.

You may not qualify if:

  • Patients did not meet the modified Duke criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Huimin Xu

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 27, 2021

Study Start

January 1, 2008

Primary Completion

December 31, 2015

Study Completion

October 20, 2016

Last Updated

July 27, 2021

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Data shared by published papers.