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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03365193
Recruitment Status : Active, not recruiting
First Posted : December 7, 2017
Last Update Posted : July 9, 2019
Information provided by (Responsible Party):
Amir Abbas Mahabadi, University Hospital, Essen

Brief 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.

Condition or disease Intervention/treatment
Infective Endocarditis Diagnostic Test: Transesophageal Echocardiography

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Study Type : Observational
Actual Enrollment : 263 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 3, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Intervention Details:
  • Diagnostic Test: Transesophageal Echocardiography
    Standard transesophageal echocardiography will be performed as clinically indicated by treating physicians.

Primary Outcome Measures :
  1. Infective Endocarditis [ Time Frame: From date of enrollment until hospital discharge, assessed up to 30 days ]
    Defined by an external clinical event committee

Secondary Outcome Measures :
  1. Presence of signs of infective endocarditis on transesophageal echocardiography as defined by judgement of the examining physician. [ Time Frame: At echocardiography examination. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will include patients with clinical indication for transesophageal echocardiography, as by decision of treating physicians.

Inclusion Criteria:

  • patients referred for echocardiographic assessment of suspected endocarditis

Exclusion Criteria:

  • Unwillingness to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03365193

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University Hospital Essen
Essen, NRW, Germany, 4
Sponsors and Collaborators
University Hospital, Essen

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Responsible Party: Amir Abbas Mahabadi, MD, coordinator cardiac trial unit, Principal Investigator, University Hospital, Essen Identifier: NCT03365193     History of Changes
Other Study ID Numbers: 17-7747-BO
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis, Subacute Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Streptococcal Infections
Gram-Positive Bacterial Infections