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RecruitingNCT05965362ENDEAVORUpdated Jul 12, 2024

Prognosis of Patients With Infective Endocarditis and Risk Stratification Value of Biomarkers (ENDEAVOR)

An observational study in Infective Endocarditis, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

In this study, by establishing a clinical cohort of infective endocarditis, we observed the natural prognosis and influencing factors in the process of disease development and regression; we used multi-omics technology to understand the prognostic value of its biomarkers, and provided new ideas and evidence for the pathogenesis, clinical diagnosis and treatment of IE.

Read the detailed description

Infective endocarditis is an inflammation of the inner lining of the heart valves or ventricular walls caused by direct infection of the heart by bacteria, fungi and other microorganisms via the bloodstream route. At present, the clinical diagnosis of IE is mainly based on a combination of typical symptoms, imaging and blood culture, etc. Finding more sensitive means and more accurate indicators for early detection of IE flora distribution characteristics is of great significance for the prevention and targeted treatment of IE. Therefore, in this study, by establishing a clinical cohort of infective endocarditis, we observed the natural prognosis and influencing factors in the process of disease development and regression; we used multi-omics technology to understand the prognostic value of its biomarkers, and provided new ideas and evidence for the pathogenesis, clinical diagnosis and treatment of IE.

02

Conditions studied

  • Infective Endocarditis

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Keywords

  • Infective Endocarditis
  • Prognosis
  • Major Adverse Cardiac and Cerebrovascular event
03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 225 across 82 observational studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with clinically confirmed infective endocarditis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with clinically confirmed infective endocarditis

Exclusion criteria

Exclusion Criteria:

  • Patients refuse to sign form
  • Patients who combined with serious systemic diseases, cannot tolerate the acquisition of biological samples
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Infective endocarditis group

    Patients diagnosed with infective endocarditis.

    Other: Observational; No Interventions were given.

Interventions

  • OtherObservational; No Interventions were given.

    Observational; No Interventions were given.

06

What researchers measure

Primary outcomes

  1. Change in the incidence of MACCE

    MACCE is major adverse cardio-cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.

    Time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

Secondary outcomes

  1. Incidence of adverse thrombus complications

    Adverse thrombus complications including systemic embolism, infected aneurysm, splenic abscess, etc.

    Time frame: 5 years after the enrollment.

  2. Change in the incidence of infection recurrence

    Diagnosis of infective endocarditis by clinical guidelines, which will be assessed from medical records.

    Time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

  3. Change in the incidence of myocardial infarction

    Myocardial infarction, diagnosed by clinical doctors, will be assessed from medical records.

    Time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

  4. Change in the incidence of stroke

    Stroke, diagnosed by clinical doctors, will be assessed from medical records.

    Time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

  5. Change in the incidence of vessel revascularization

    Vessel revascularization, diagnosed by clinical doctors, will be assessed from medical records.

    Time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

  6. Change in the incidence of all-cause death

    All-cause death, diagnosed by clinical doctors, will be assessed from medical records.

    Time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Dec 2028, 55 months after the start.

Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's planned 55 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2023
First posted
Jul 28, 2023
StartActual
May 9, 2024
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Jul 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05965362
Collaborators
521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
Responsible party
Sponsor
First posted
Jul 28, 2023
Start date
May 9, 2024
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jul 12, 2024

Study contacts

Guoliang Li
Contact
liguoliang_med@163.com
+8613759982523
Yang Yan
Contact
yangyan3@xjtu.edu.cn
+8613259882601
Yang Yan
principal investigator · First Affiliated Hospital Xi'an Jiaotong University
Guoliang Li
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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