Clinical Trials Directory

Trials / Completed

CompletedNCT03365193

PRetest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities (PRO ENDOCARDITIS ECHO-Study)

Retest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities

Status
Completed
Phase
Study type
Observational
Enrollment
263 (actual)
Sponsor
University Hospital, Essen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Infective endocarditis is a potentially lethal disease that has undergone major changes over the last decades. The Duke Criteria are recommended for evaluation of probability of presence of infective endocarditis by current ESC guidelines. However, since the introduction of Duke criteria in 1994, characteristics of patients presenting with potential infective endocarditis have substantially changed, especially in tertiary care facilities, towards a high proportion of patients with immune deficiency (caused by illness or medically induced), critically ill patients, patients with prosthetic valves and patients with long-lasting intensive care treatment. Likewise, with the increasing interventional therapy of structural heart disease and device implantation in older and multi-morbid patient cohorts, the frequency of endocarditis on prosthetic material and devices increased over the last decades. While Duke criteria overall misclassify a substantial proportion of patients with endocarditis, Duke criteria are difficult to apply in these patients because of lower sensitivity. Therefore, several modifications of the Duke criteria have been proposed. In addition, the uncertainty regarding potential infective endocarditis of treating physicians due to clinical characteristics of their patients leads to an increase in requests for transthoracic and transesophageal echocardiography, overcoming echocardiography laboratories. In the present study the investigators aim to identify (I) the precision of the Duke score in predicting presence of infective endocarditis in patients examined at the echocardiography laboratory of the West German Heart Center (II) determine characteristics, not including echocardiography that are associated with increased risk of infective endocarditis, justifying transesophageal echocardiography examination and (III) establish scoring algorithms to help treating physicians to assess the risk of endocarditis in severely diseased patient cohorts prior to echocardiography examinations and to avoid unnecessary echo exams.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTTransesophageal EchocardiographyStandard transesophageal echocardiography will be performed as clinically indicated by treating physicians.

Timeline

Start date
2017-12-01
Primary completion
2019-05-03
Completion
2021-10-07
First posted
2017-12-07
Last updated
2021-10-08

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03365193. Inclusion in this directory is not an endorsement.