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Clinical Trials/NCT05965362
NCT05965362RecruitingNot Applicable

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

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country2,000 target enrollmentStarted: May 9, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
2,000
Locations
1
Primary Endpoint
Change in the incidence of MACCE

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Change in the incidence of myocardial infarction(1, 3, 6 months and 1, 2, 3, 5 years after enrollment.)
  • Incidence of adverse thrombus complications(5 years after the enrollment.)
  • Change in the incidence of stroke(1, 3, 6 months and 1, 2, 3, 5 years after enrollment.)
  • Change in the incidence of all-cause death(1, 3, 6 months and 1, 2, 3, 5 years after enrollment.)
  • Change in the incidence of infection recurrence(1, 3, 6 months and 1, 2, 3, 5 years after enrollment.)
  • Change in the incidence of vessel revascularization(1, 3, 6 months and 1, 2, 3, 5 years after enrollment.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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