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

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ClinicalTrials.gov Identifier: NCT05965362
Recruitment Status : Not yet recruiting
First Posted : July 28, 2023
Last Update Posted : April 4, 2024
Sponsor:
Collaborators:
521 Hospital of NORINCO Group
Shaanxi Provincial People's Hospital
Xiangyang Central Hospital
Henan Provincial People's Hospital
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Study Description
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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.

Condition or disease Intervention/treatment
Infective Endocarditis Other: Observational; No Interventions were given.

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
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Other
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
Estimated Study Start Date : December 31, 2024
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood, feces, urine, valvular, superfluous organisms, adipose tissue and pericardial effusion.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with clinically confirmed infective endocarditis
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05965362


Contacts
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Contact: Guoliang Li +8613759982523 liguoliang_med@163.com
Contact: Yang Yan +8613259882601 yangyan3@xjtu.edu.cn

Locations
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China, Shaanxi
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, China, 710061
Contact: Guoliang Li    008613759982523    liguoliang_med@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
521 Hospital of NORINCO Group
Shaanxi Provincial People's Hospital
Xiangyang Central Hospital
Henan Provincial People's Hospital
Investigators
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Principal Investigator: Yang Yan First Affiliated Hospital Xi'an Jiaotong University
Principal Investigator: Guoliang Li First Affiliated Hospital Xi'an Jiaotong University
More Information
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT05965362    
Other Study ID Numbers: XJTU1AF2023LSK-151
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: April 4, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Infective Endocarditis
Prognosis
Major Adverse Cardiac and Cerebrovascular event
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Cardiovascular Infections