NCT05965362

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started May 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
May 2024Dec 2028

First Submitted

Initial submission to the registry

February 14, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

May 9, 2024

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4.6 years

First QC Date

February 14, 2023

Last Update Submit

July 10, 2024

Conditions

Keywords

Infective EndocarditisPrognosisMajor Adverse Cardiac and Cerebrovascular event

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Incidence of adverse thrombus complications

    5 years after the 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 myocardial infarction

    1, 3, 6 months and 1, 2, 3, 5 years after enrollment.

  • Change in the incidence of stroke

    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.

  • +1 more secondary outcomes

Study Arms (1)

Infective endocarditis group

Patients diagnosed with infective endocarditis.

Other: Observational; No Interventions were given.

Interventions

Observational; No Interventions were given.

Infective endocarditis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinically confirmed infective endocarditis

You may qualify if:

  • Patients with clinically confirmed infective endocarditis

You may not qualify if:

  • Patients refuse to sign informed consent form
  • Patients who combined with serious systemic diseases, cannot tolerate the acquisition of biological samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, feces, urine, valvular, superfluous organisms, adipose tissue and pericardial effusion.

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Yang Yan

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR
  • Guoliang Li

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

July 28, 2023

Study Start

May 9, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 12, 2024

Record last verified: 2024-03

Locations