Clinical trial NCT05965362: Prognosis of Patients With Infective Endocarditis and Risk Stratification Value of Biomarkers (ENDEAVOR）
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infective Endocarditis
Keywords: Infective Endocarditis
Prognosis
Major Adverse Cardiac and Cerebrovascular event
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: 521 Hospital of NORINCO Group
name: Shaanxi Provincial People's Hospital
name: Xiangyang Central Hospital
name: Henan Provincial People's Hospital
First posted: 2023-07-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically confirmed infective endocarditis

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the incidence of MACCE
timeFrame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Secondary outcomes:
measure: Incidence of adverse thrombus complications
timeFrame: 5 years after the enrollment.
measure: Change in the incidence of infection recurrence
timeFrame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
measure: Change in the incidence of myocardial infarction
timeFrame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
measure: Change in the incidence of stroke
timeFrame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
measure: Change in the incidence of vessel revascularization
timeFrame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
measure: Change in the incidence of all-cause death
timeFrame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
References: