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

Infective Endocarditis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965362
• Other study ID #: XJTU1AF2023LSK-151
• Status: Not yet recruiting
• Start date: December 31, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang Li
• Phone: +8613759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

Other:
• Observational; No Interventions were given.
Observational; No Interventions were given.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	521 Hospital of NORINCO Group, Henan Provincial People's Hospital, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Secondary	Incidence of adverse thrombus complications	Adverse thrombus complications including systemic embolism, infected aneurysm, splenic abscess, etc.	5 years after the enrollment.
Secondary	Change in the incidence of infection recurrence	Diagnosis of infective endocarditis by clinical guidelines, which will be assessed from medical records.	1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Secondary	Change in the incidence of myocardial infarction	Myocardial infarction, diagnosed by clinical doctors, will be assessed from medical records.	1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Secondary	Change in the incidence of stroke	Stroke, diagnosed by clinical doctors, will be assessed from medical records.	1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Secondary	Change in the incidence of vessel revascularization	Vessel revascularization, diagnosed by clinical doctors, will be assessed from medical records.	1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Secondary	Change in the incidence of all-cause death	All-cause death, diagnosed by clinical doctors, will be assessed from medical records.	1, 3, 6 months and 1, 2, 3, 5 years after enrollment.