An observational study in Infective Endocarditis, sponsored by University Hospital, Essen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by University Hospital, Essen · Observational
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's enrollment of 263 is above the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →University Hospital, Essen is the lead sponsor of 118 studies on the registry; 35 are open to participants now.
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The study will include patients with clinical indication for transesophageal echocardiography, as by decision of treating physicians.
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Exclusion Criteria:
Standard transesophageal echocardiography will be performed as clinically indicated by treating physicians.
Infective Endocarditis
Defined by an external clinical event committee
Time frame: From date of enrollment until hospital discharge, assessed up to 30 days
Presence of signs of infective endocarditis on transesophageal echocardiography as defined by judgement of the examining physician.
Time frame: At echocardiography examination.
Ran from Dec 2017 to primary completion in May 2019, 17 months.
Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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