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NCT Number: NCT05965362

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

Location status: Recruiting

Location contact

Guoliang Li

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with clinically confirmed infective endocarditis

Exclusion criteria

  • Patients refuse to sign informed consent form
  • Patients who combined with serious systemic diseases, cannot tolerate the acquisition of biological samples

Treatment and study plan

Observational; No Interventions were given.

Other

Observational; No Interventions were given.

Primary outcomes

  1. Change in the incidence of MACCE

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

    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.

Secondary outcomes

  1. Incidence of adverse thrombus complications

    Time frame: 5 years after the enrollment.

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

  2. Change in the incidence of infection recurrence

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

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

  3. Change in the incidence of myocardial infarction

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

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

  4. Change in the incidence of stroke

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

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

  5. Change in the incidence of vessel revascularization

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

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

  6. Change in the incidence of all-cause death

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • 521 Hospital of NORINCO Group
  • Henan Provincial People's Hospital
  • Shaanxi Provincial People's Hospital
  • Xiangyang Central Hospital

Registry information

Official study title

Prognosis of Patients With Infective Endocarditis and Risk Stratification Value of Biomarkers (ENDEAVOR): a National Multi-center, Retrospective-prospective, Cohort Study Initiated by the Investigators

Acronym: ENDEAVOR

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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