Infective EndocarditisNCT04977518
Characteristics of Infective Endocarditis in East China
An observational study of Infective Endocarditis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infective Endocarditis
- How many people
- 183 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 20 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients with a clinical diagnosis of infective endocarditis.
Who cannot join
- Patients did not meet the modified Duke criteria.
About this study
Official title: Study of the Clinical Presentations, Treatment and Outcomes of Infective Endocarditis Patients in a Tertiary Hospital in East China
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.
Read the detailed description
Infective endocarditis (IE) is a rare but life-threatening serious disease that still has a high mortality, even in developed countries. The objective of this study was to evaluate the clinical presentations, treatment and outcomes of IE patients in a tertiary hospital in East China over an 8-year period. This was a retrospective observational study of consecutive cases of definite or possible IE as per the modified Duke criteria between January 2008 and December 2015.
- Conditions
- Infective Endocarditis
- Being tested
- no intervention
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed during 2008-2011 | Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2008-2011 Receives: 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 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications (neurological events, systemic embolism, and congestive heart failure) of infective endocarditis
- A neurological event was defined as symptomatic or asymptomatic stroke, hemorrhage, or encephalopathy.
- Systemic embolization was defined as an embolic event outside of the central nervous system.
- Congestive heart failure was defined as with class III, or IV heart failure and an ejection fraction of 40% or less.
Measured: During the hospitalization, average of 1 months
Mortality
Patients dead or moribund before discharge
Measured: During the hospitalization, average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Jan 2008
- Primary completion31 Dec 2015
- Study completion20 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huimin Xu, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977518
- Sponsor's protocol ID
- 2015-046
- Status last verified
- Mar 2016
- First submitted
- 13 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data shared by published papers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical Presentations, Treatment and Outcomes of Infective Endocarditis Patients in a Tertiary Hospital in East China
- ClinicalTrials.gov ID
- NCT04977518
- Acronym / sponsor ID
- 2015-046
- Conditions
- Infective Endocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 27 Jul 2021 (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.
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.
Detailed description
Infective endocarditis (IE) is a rare but life-threatening serious disease that still has a high mortality, even in developed countries. The objective of this study was to evaluate the clinical presentations, treatment and outcomes of IE patients in a tertiary hospital in East China over an 8-year period. This was a retrospective observational study of consecutive cases of definite or possible IE as per the modified Duke criteria between January 2008 and December 2015.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed during 2008-2011 | – | Other: no interventionPatients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2008-2011 |
| Patients diagnosed during 2012-2015 | – | Other: no interventionPatients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2012-2015 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with a clinical diagnosis of infective endocarditis.
Key exclusion criteria (1 listed)
- Patients did not meet the modified Duke criteria.
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 |
|---|---|---|
| no interventionno intervention | Other | Patients diagnosed during 2008-2011, Patients diagnosed during 2012-2015 |
Primary outcome
Complications (neurological events, systemic embolism, and congestive heart failure) of infective endocarditis
Time frame: During the hospitalization, average of 1 months
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.
Mortality
Time frame: During the hospitalization, average of 1 months
Patients dead or moribund before discharge
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 27 Jul 2021.
- Individual participant dataSharing planned: No. Data shared by published papers.
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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.
Huimin Xu principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 27 Jul 2021. 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?
Complications (neurological events, systemic embolism, and congestive heart failure) of infective endocarditis (time frame: During the hospitalization, average of 1 months). The study lists 2 primary outcomes in all. 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 27 Jul 2021.