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

July 10, 2024 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xian Jiantong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with clinically confirmed infective endocarditis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infective endocarditis group
Patients diagnosed with infective endocarditis.
Other: Observational; No Interventions were given.
Observational; No Interventions were given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse thrombus complications
Time Frame: 5 years after the enrollment.
Adverse thrombus complications including systemic embolism, infected aneurysm, splenic abscess, etc.
5 years after the enrollment.
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.
1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
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.
1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
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.
1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
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.
1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
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.
1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

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

Investigators

  • Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University
  • Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2023LSK-151

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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