Infective EndocarditisNCT03365193
PRetest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities (PRO ENDOCARDITIS ECHO-Study)
An observational study of Infective Endocarditis, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- Transesophageal Echocardiography
- How many people
- 263 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2017to 7 Oct 2021
- 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: The study will include patients with clinical indication for transesophageal echocardiography, as by decision of treating physicians.
Who may be able to join
- patients referred for echocardiographic assessment of suspected endocarditis
Who cannot join
- Unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities
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
- Infective Endocarditis
- Being tested
- Transesophageal Echocardiography
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal EchocardiographyDiagnostic test
Standard transesophageal echocardiography will be performed as clinically indicated by treating physicians.
What is being measured
The primary outcome is the main question the study is designed to answer.
Infective Endocarditis
Defined by an external clinical event committee
Measured: From date of enrollment until hospital discharge, assessed up to 30 days
Secondary outcomes (1)
Presence of signs of infective endocarditis on transesophageal echocardiography as defined by judgement of the examining physician.
Measured: At echocardiography examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Dec 2017
- Primary completion3 May 2019
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies 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
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Abbas Mahabadi, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365193
- Sponsor's protocol ID
- 17-7747-BO
- Status last verified
- Oct 2021
- First submitted
- 1 Dec 2017
- Last updated
- 8 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mahabadi AA, Mahmoud I, Dykun I, Totzeck M, Rath PM, Ruhparwar A, Buer J, Rassaf T. Diagnostic value of the modified Duke criteria in suspected infective endocarditis -The PRO-ENDOCARDITIS study. Int J Infect Dis. 2021 Mar;104:556-561. doi: 10.1016/j.ijid.2021.01.046. Epub 2021 Jan 27.
PubMed 33508475
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities
- ClinicalTrials.gov ID
- NCT03365193
- Acronym / sponsor ID
- 17-7747-BO
- Conditions
- Infective Endocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 7 Dec 2017 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients with clinical indication for transesophageal echocardiography, as by decision of treating physicians.
Key inclusion criteria (1 listed)
- patients referred for echocardiographic assessment of suspected endocarditis
Key exclusion criteria (1 listed)
- Unwillingness to participate.
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 |
|---|---|---|
| Transesophageal EchocardiographyStandard transesophageal echocardiography will be performed as clinically indicated by treating physicians. | Diagnostic test | – |
Primary outcome
Infective Endocarditis
Time frame: From date of enrollment until hospital discharge, assessed up to 30 days
Defined by an external clinical event committee
1 secondary outcome
Presence of signs of infective endocarditis on transesophageal echocardiography as defined by judgement of the examining physician.
Time frame: At echocardiography examination.
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 8 Oct 2021.
- Derived from this study: PubMed 33508475Mahabadi AA, Mahmoud I, Dykun I, Totzeck M, Rath PM, Ruhparwar A, Buer J, Rassaf T. Diagnostic value of the modified Duke criteria in suspected infective endocarditis -The PRO-ENDOCARDITIS study. Int J Infect Dis. 2021 Mar;104:556-561. doi: 10.1016/j.ijid.2021.01.046. Epub 2021 Jan 27.
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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, run by University Hospital, Essen at 1 site in Germany.
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 1 inclusion and 1 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 8 Oct 2021. 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 Germany. 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?
Infective Endocarditis (time frame: From date of enrollment until hospital discharge, assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03365193, which also lists 1 linked publication.
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 8 Oct 2021.