Clinical and Diagnostic Features of Endocarditis
ConditionEndocarditis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Ferrara
About this trial
The burden of endocarditis has changed in the last years due to an increase in percutaneous valve procedures offered to a more fragile, and old population. Therefore an update in epidemiology data is necessary. The Observational prospective multicenter study to characterize the cLinical ANd DiagnoStiC feAtures of endocarditis in the contemPorary Era, (ENDO-LANDSCAPE study) is an observational, multicenter and international study. The study has two arms: retrospective and prospective.
The retrospective arm will involve collecting data from patients discharged with a diagnosis of endocarditis between 2016 and 2022. The data obtained in the retrospective arm of the study will be utilized in a power calculation to determine the sample size for the prospective arm of the study. In the prospective phase in every participating center, all patients referred for echocardiography to assess for endocarditis and those with established endocarditis independent of the screened request will be eligible. Patients will then be stratified according to the presence or abscence of endocarditis. Those with an established diagnosis of endocarditis will be prospectively followed for outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients above the age of 18 years.
all consecutive patients referred for echocardiography (transthoracic or transesophageal approach) to exclude endocarditis.
patients with a diagnosis of endocarditis on echocardiography independently by the request for the exam.
Disqualifiers
patient's refusal.
Trial population
All consecutive patients referred for a echocardiography with a suspicion of bacterial endocarditis and those with a confirmed diagnosis of endocarditis independently by the request will potentially be eligible for the study. Only the patients with a positive findings of endocarditis will be prospectively followed for one year. For patients with no evidence of endocarditis on their echocardiogram, data on the following will be collected: i) size, type and position of valve prosthesis; ii) Duke criteria verification.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
advanced cardiac imaging
Diagnostic testIn all patients with high suspected or confirmed endocarditis at the echocardiography the following information will be collected: 1) endocarditis risk factors, 2) type, size and position of infected valve or prosthesis, 3) echocardiographic data; 4) imaging technique used for diagnosis in addition to echocardiography; 5) management of the case performed by the endocarditis team (including cardiologist, microbiologist, cardiac surgeon, radiologist); 6) Duke criteria verification; 7) management of the case (conservative or invasive); 8) antibiotic therapy prescribed and timing; 9) follow-up at one year (death, cardiac surgery, stroke, re-infection).
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: definite or high suspicion endocarditis1 intervention
Group B: negative examination with low suspicion of endocarditis1 intervention
Trial outcomes
Primary outcomes
1
incidence of endocarditis
the incidence of endocarditis in patients with native valve, surgical implanted prosthesis, percutaneously corrected valve disease, other devices
Time frame
1 yearSecondary outcomes
1
Appropriateness of requests for echocardiography to exclude endocarditis
The investigator will asses based on clinical and laboratory data if the suspicion of endocarditis was reliable and then the request of echocardiography appropriate
Time frame
day 12
All-cause mortality of surgically treated endocarditis
All-cause mortality of surgically treated endocarditis
Time frame
1 year3
All-cause mortality of medically managed endocarditis
All-cause mortality of medically managed endocarditis
Time frame
1 year4
Cerebrovascular accident
Cumulative occurrence of ischemic stroke and transient ischemic attack
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov