To prospectively evaluate the diagnostic accuracy of dynamic cardiac CT in addition to and in comparison with TEE in unselected patients with a clinical suspicion of native valve endocarditis.
ID
Source
Brief title
Condition
- Endocardial disorders
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic accuracy of dynamic cardiac CT in additon to and in comparison
with TEE.
Secondary outcome
-Cost effectiveness analysis of dynamic cardiac CT in addition to and in
comparison with TEE.
-Retrospectively allocated treatment strategy based dynamic cardiac CT in
addition to and in comparison with TEE.
-Interobserver variability of dynamic cardiac CT regarding the diagnosis NVE.
Background summary
Infective endocarditis (IE) is a disease with a high in-hospital mortality,
morbidity, and complication rate . The diagnosis of IE is often challenging and
is based on imaging criteria amongst others. According to the current European
and Dutch guidelines transoesophageal echocardiography (TEE) is frequently
used. TEE is a semi-invasive procedure sometimes requiring sedation. However,
current literature shows that the diagnostic accuracy of dynamic cardiac
computed tomography (CT) is more or less comparable to TEE in a selected
population of mostly pre-operative and complicated IE patients.
Study objective
To prospectively evaluate the diagnostic accuracy of dynamic cardiac CT in
addition to and in comparison with TEE in unselected patients with a clinical
suspicion of native valve endocarditis.
Study design
Single centre, prospective cohort study.
Study burden and risks
There is a small risk for patient as patients will undergo a dynamic cardiac
CT. For a dynamic cardiac CT the average radiation dose is 3 millisieverts and
average 60-70 ml of iodine contrast will be used. Futheremore, all patients
will be contacted once by telephone six month after hospitalization to screen
for complications.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
-Patients aged > 18 years old hospitalized at the Radboudumc with a clinical
suspicion of infective endocarditis
-Positive blood cultures
-Clinical indication for TEE, according to current guideline recommendations
Exclusion criteria
-Pregnancy or breastfeeding
-Prosthetic heart valve
-Cardiovascular implantable electronic device
-Body mass index > 35 kg/m2
-Glomerular filtration rate < 30 mL/min/1.73 m2
-Previous allergic reaction to iodine contrast dye
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80816.091.22 |