Infective Endocarditis (IE)ETCEINCT07529730
Outcomes of Surgical Treatment in Patients With Infective Endocarditis
An observational study of Infective Endocarditis (IE), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
Infective endocarditis (IE) is a severe disease associated with significant morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. In complicated cases, surgical intervention is frequently required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis (IE)
- What is being tested?
- Data collection
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 16 Apr 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 who underwent surgery for infective endocarditis between 2019 and 2024
Who may be able to join
- Age ≥ 18
- Patients admitted to the AOU AL and undergoing surgery between 2019 and 2024 for infectious endocarditis with ICD-9 diagnosis:
- O 4210 -Acute and subacute bacterial endocarditis O 4211-Acute and subacute infectious endocarditis in diseases Classified elsewhere O 4219 -Unspecified acute endocarditis O 42490 -Endocarditis, unspecified valve, specify Specified O 42491 -Endocarditis in diseases classified elsewhere O 42499 -Other endocarditis, valves not specified
- Signature of informed consent
Who cannot join
- Incomplete medical records or records with data missing that is relevant to this study
- Severely immunocompromised patients (e.g. organ transplant patients, patients undergoing intensive chemotherapy, patients with advanced AIDS, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Surgical Treatment in Patients With Infective Endocarditis: a Retrospective Observational Study
Infective endocarditis (IE) is a severe disease associated with significant morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. In complicated cases, surgical intervention is frequently required.
This retrospective observational study aims to evaluate outcomes in adult patients undergoing cardiac surgery for infective endocarditis at the Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo of Alessandria. The primary objective is to assess 30-day mortality after surgery and to analyze clinical and surgical factors associated with adverse outcomes.
Secondary objectives include the description of epidemiological, clinical, microbiological, and therapeutic characteristics of surgically treated infective endocarditis, the identification of predictors of postoperative complications, and the evaluation of mortality and recurrence of infection at 6 and 12 months after surgery. The study also assesses the consistency between documented surgical indications and the recommendations of the European Society of Cardiology (ESC) guidelines for the management of infective endocarditis.
Read the detailed description
Infective endocarditis (IE) remains a severe disease associated with high morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. Surgical treatment is often required in complicated cases, such as severe valvular dysfunction, uncontrolled infection, or high embolic risk.
IE is characterized by the formation of vegetations, defined as pathological masses composed of fibrin, platelets, white blood cells, and microorganisms. These lesions mainly involve native or prosthetic cardiac valves but may occasionally develop on other endocardial devices.The microorganisms most frequently responsible for complicated forms of infective endocarditis are typically aggressive pathogens or organisms with resistance to antimicrobial therapy. In recent years, the incidence of infective endocarditis appears to show a continuous increasing trend. This increase may be related to several factors, including the aging of the population, the growing use of implantable cardiac devices, and changes in antibiotic prophylaxis strategies. These epidemiological changes highlight the need for continuous evaluation and improvement of diagnostic and therapeutic strategies for a disease that remains associated with substantial morbidity and mortality.
This retrospective observational study includes all adult patients who underwent cardiac surgery for infective endocarditis between 2019 and 2024 at the University Hospital of Alessandria. The diagnosis of infective endocarditis is defined according to the modified Duke criteria and is retrospectively confirmed based on the available clinical documentation.
The study also evaluates the consistency between documented surgical indications and the recommendations of the current European Society of Cardiology (ESC) guidelines for the management of infective endocarditis.
- Conditions
- Infective Endocarditis (IE)
- Being tested
- Data collection
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Patients retrospectively enrolled who underwent surgery for infective endocarditis between 2019 and 2024.
Data are collected in a dedicated electronic database.
| Study group | Role | What they receive |
|---|---|---|
| Infective endocarditis (IE) | Patients who have undergone surgery for infective endocarditis Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality after cardiac surgery for infective endocarditis
Evaluation of mortality occurring within 30 days after cardiac surgery for infective endocarditis.
Measured: Until the completion of the study, which is expected to last approximately 12 months.
Secondary outcomes (8)
Patient characteristics in complicated infective endocarditis
Describe the characteristics of patients undergoing cardiac surgery for complicated infective endocarditis.
Measured: Until the completion of the study, which is expected to last approximately 12 months.
Predictors of postoperative complications
Identification of possible predictors of post-operative complications (infections, thromboembolic events, organ failure, need for reoperation) in patients undergoing cardiac surgery for infective endocarditis.
Measured: Until the completion of the study, which is expected to last approximately 12 months.
Consistency of surgical indications with ESC guideline recommendations
Assessment of the concordance between the surgical indications documented for patients with complicated infective endocarditis and the recommendations of the 2023 European Society of Cardiology (ESC) guidelines.
Measured: Until the completion of the study, which is expected to last approximately 12 months.
Assessment of microorganisms
Assessment of microorganisms based on antibiogram in relation to an increased probability of post-operative complications.
Measured: Until the completion of the study, which is expected to last approximately 12 months.
All-cause mortality at 6 months
All-cause mortality within 6 months after cardiac surgery for complicated infective endocarditis.
Measured: 6 months post-surgery.
All-cause mortality at 12 months
All-cause mortality within 12 months after cardiac surgery for complicated infective endocarditis.
Measured: 12 months post-surgery.
Infectious recurrence at 6 months
Recurrence of infective endocarditis or related infection within 6 months after surgery.
Measured: 6 months post-surgery.
Infectious recurrence at 12 months
Recurrence of infective endocarditis or related infection within 12 months after surgery.
Measured: 12 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start16 Apr 2025
- Primary completion23 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective Endocarditis (IE)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529730
- Sponsor's protocol ID
- ASO.Cch.25.02
- Acronym
- ETCEI
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Surgical Treatment in Patients With Infective Endocarditis: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07529730
- Acronym / sponsor ID
- ETCEI / ASO.Cch.25.02
- Conditions
- Infective Endocarditis (IE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Apr 2026 (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.
Infective endocarditis (IE) is a severe disease associated with significant morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. In complicated cases, surgical intervention is frequently required.
This retrospective observational study aims to evaluate outcomes in adult patients undergoing cardiac surgery for infective endocarditis at the Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo of Alessandria. The primary objective is to assess 30-day mortality after surgery and to analyze clinical and surgical factors associated with adverse outcomes.
Secondary objectives include the description of epidemiological, clinical, microbiological, and therapeutic characteristics of surgically treated infective endocarditis, the identification of predictors of postoperative complications, and the evaluation of mortality and recurrence of infection at 6 and 12 months after surgery. The study also assesses the consistency between documented surgical indications and the recommendations of the European Society of Cardiology (ESC) guidelines for the management of infective endocarditis.
Detailed description
Infective endocarditis (IE) remains a severe disease associated with high morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. Surgical treatment is often required in complicated cases, such as severe valvular dysfunction, uncontrolled infection, or high embolic risk.
IE is characterized by the formation of vegetations, defined as pathological masses composed of fibrin, platelets, white blood cells, and microorganisms. These lesions mainly involve native or prosthetic cardiac valves but may occasionally develop on other endocardial devices.The microorganisms most frequently responsible for complicated forms of infective endocarditis are typically aggressive pathogens or organisms with resistance to antimicrobial therapy. In recent years, the incidence of infective endocarditis appears to show a continuous increasing trend. This increase may be related to several factors, including the aging of the population, the growing use of implantable cardiac devices, and changes in antibiotic prophylaxis strategies. These epidemiological changes highlight the need for continuous evaluation and improvement of diagnostic and therapeutic strategies for a disease that remains associated with substantial morbidity and mortality.
This retrospective observational study includes all adult patients who underwent cardiac surgery for infective endocarditis between 2019 and 2024 at the University Hospital of Alessandria. The diagnosis of infective endocarditis is defined according to the modified Duke criteria and is retrospectively confirmed based on the available clinical documentation.
The study also evaluates the consistency between documented surgical indications and the recommendations of the current European Society of Cardiology (ESC) guidelines for the management of infective endocarditis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infective endocarditis (IE) | – | Other: Data collectionPatients who have undergone surgery for infective endocarditis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgery for infective endocarditis between 2019 and 2024
Key inclusion criteria (4 listed)
- Age ≥ 18
- Patients admitted to the AOU AL and undergoing surgery between 2019 and 2024 for infectious endocarditis with ICD-9 diagnosis:
- O 4210 -Acute and subacute bacterial endocarditis O 4211-Acute and subacute infectious endocarditis in diseases Classified elsewhere O 4219 -Unspecified acute endocarditis O 42490 -Endocarditis, unspecified valve, specify Specified O 42491 -Endocarditis in diseases classified elsewhere O 42499 -Other endocarditis, valves not specified
- Signature of informed consent
Key exclusion criteria (2 listed)
- Incomplete medical records or records with data missing that is relevant to this study
- Severely immunocompromised patients (e.g. organ transplant patients, patients undergoing intensive chemotherapy, patients with advanced AIDS, etc.)
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 |
|---|---|---|
| Data collectionPatients retrospectively enrolled who underwent surgery for infective endocarditis between 2019 and 2024. Data are collected in a dedicated electronic database. | Other | Infective endocarditis (IE) |
Primary outcome
30-day mortality after cardiac surgery for infective endocarditis
Time frame: Until the completion of the study, which is expected to last approximately 12 months.
Evaluation of mortality occurring within 30 days after cardiac surgery for infective endocarditis.
8 secondary outcomes
Patient characteristics in complicated infective endocarditis
Time frame: Until the completion of the study, which is expected to last approximately 12 months.
Predictors of postoperative complications
Time frame: Until the completion of the study, which is expected to last approximately 12 months.
Consistency of surgical indications with ESC guideline recommendations
Time frame: Until the completion of the study, which is expected to last approximately 12 months.
Assessment of microorganisms
Time frame: Until the completion of the study, which is expected to last approximately 12 months.
All-cause mortality at 6 months
Time frame: 6 months post-surgery.
All-cause mortality at 12 months
Time frame: 12 months post-surgery.
Infectious recurrence at 6 months
Time frame: 6 months post-surgery.
Infectious recurrence at 12 months
Time frame: 12 months post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (IE), run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 14 Apr 2026. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality after cardiac surgery for infective endocarditis (time frame: Until the completion of the study, which is expected to last approximately 12 months.). 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 14 Apr 2026.