Infective EndocarditisENDEAVORNCT05965362
Prognosis of Patients With Infective Endocarditis and Risk Stratification Value of Biomarkers (ENDEAVOR）
An observational study of Infective Endocarditis, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically confirmed infective endocarditis
Who may be able to join
- Patients with clinically confirmed infective endocarditis
Who cannot join
- Patients refuse to sign informed consent form
- Patients who combined with serious systemic diseases, cannot tolerate the acquisition of biological samples
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, liguoliang_med@163.com
About this study
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
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.
Read the 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.
- Conditions
- Infective Endocarditis
- Being tested
- Observational; No Interventions were given.
- Keywords
- Infective Endocarditis, Prognosis, Major Adverse Cardiac and Cerebrovascular event
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational; No Interventions were given.Other
Observational; No Interventions were given.
| Study group | Role | What they receive |
|---|---|---|
| Infective endocarditis group | Patients diagnosed with infective endocarditis. Receives: Other: Observational; No Interventions were given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Secondary outcomes (6)
Incidence of adverse thrombus complications
Adverse thrombus complications including systemic embolism, infected aneurysm, splenic abscess, etc.
Measured: 5 years after the enrollment.
Change in the incidence of infection recurrence
Diagnosis of infective endocarditis by clinical guidelines, which will be assessed from medical records.
Measured: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Change in the incidence of myocardial infarction
Myocardial infarction, diagnosed by clinical doctors, will be assessed from medical records.
Measured: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Change in the incidence of stroke
Stroke, diagnosed by clinical doctors, will be assessed from medical records.
Measured: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Change in the incidence of vessel revascularization
Vessel revascularization, diagnosed by clinical doctors, will be assessed from medical records.
Measured: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Change in the incidence of all-cause death
All-cause death, diagnosed by clinical doctors, will be assessed from medical records.
Measured: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start9 May 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityGuoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965362
- Sponsor's protocol ID
- XJTU1AF2023LSK-151
- Acronym
- ENDEAVOR
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05965362
- Acronym / sponsor ID
- ENDEAVOR / XJTU1AF2023LSK-151
- Conditions
- Infective Endocarditis
- Keywords
- Infective Endocarditis, Prognosis, Major Adverse Cardiac and Cerebrovascular event
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- 521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
- Study start
- 9 May 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infective endocarditis group | – | Other: Observational; No Interventions were given.Patients diagnosed with infective endocarditis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically confirmed infective endocarditis
Key inclusion criteria (1 listed)
- Patients with clinically confirmed infective endocarditis
Key exclusion criteria (2 listed)
- Patients refuse to sign informed consent form
- Patients who combined with serious systemic diseases, cannot tolerate the acquisition of biological samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational; No Interventions were given.Observational; No Interventions were given. | Other | Infective endocarditis group |
Primary outcome
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.
6 secondary outcomes
Incidence of adverse thrombus complications
Time frame: 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.
Change in the incidence of myocardial infarction
Time frame: 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.
Change in the incidence of vessel revascularization
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Guoliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoliang Li (+8613759982523, liguoliang_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of MACCE (time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.