To determine normal FDG-uptake around PHV*s in aortic position.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
18F-FDG/PET baseline uptake measured by the QVSH value and the SUV ratio*s
around the PHV in early, late and possibly also in the chronic postoperative
phase: 5 (± 1) weeks, 12 (± 2) weeks and 12 (± 2) months respectively.
Secondary outcome
- Feasibility of hybrid fusion (diagnostic CTA and PET): percentage of
patients for which it is possible to fuse FDG-PET images and cardiac CTA
images
- Artefacts (region, extend and type and location) during assessment with
FDG-PET/CTA will be described
Background summary
Prosthetic Heart Valve (PHV) endocarditis is complicated by peri-annular
extension (abscesses/mycotic aneurysms) in up to 50% of patients and has an
in-hospital mortality of approximately 30%. However, with current standard
imaging tools such as Echocardiography and Computed Tomography Angiography
(CTA), it remains difficult to detect peri-annular extension, which is an
indication for urgent surgery in order to reduce mortality. Furthermore, if
peri-annular abnormalities are found with imaging, differentiation between
active and non-active inflammatory tissue is impossible, because of the lack of
metabolic information. Hybrid imaging with combined anatomical information by
CTA and metabolic information by FDG-PET may provide this additional
information. However, normal baseline FDG uptake at different time points after
aortic PHV implantation is unknown and obligatory for correct interpretation of
CTA/PET scans in PHV patients.
Study objective
To determine normal FDG-uptake around PHV*s in aortic position.
Study design
Prospective multicentre cross-sectional study.
Included patients receive one 18-F FDG-PET/CTA after implantation of a PHV in
aortic position. There is no control group or follow-up. Only 18-F FDG-PET/CTA
results will be used for data analysis.
Study burden and risks
Risk: Prospectively ECG-triggered CTA and FDG-PET exposes the patient to a
combined maximum radiation dose of 10.0 milli Sievert (mSv) which is
approximately 4-5 times the annual natural background radiation. The risk of
contrast-induced nephropathy (CIN) is minimal because of exclusion of patients
with diminished renal function. In addition the risk of contrast media induced
severe acute general reactions is 0.04% per patient. Co-incidental findings
with FDG-PET and CTA are reduced to a minimum, because only the region of the
heart/aortic root with PHV is scanned. In case of a co-incidental finding
patients are informed and if needed further investigation is offered
Benefit: Asymptomatic postoperative PHV dysfunction may be detected in an early
stage. Ascertaining the normal pattern of metabolic activity with FDG-PET
surrounding PHVs will be of added value in the future evaluation of individual
patients in this study and possibly for all FDG-PET studies performed worldwide
on other patients with PHVs.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- age > 50 years
- patients after uncomplicated PHV implantation
- Normal routine follow-up TTE
- 5 weeks or 12 weeks or 12 months after PHV implantation
- weight < 110 kg
Exclusion criteria
- Known contrast allergy
- Known renal impairment (GFR<60)
- Other contraindications for contrast use according the standard daily clinical routine
- Use of pericardial patches and re-operation of aortic PHV in past medical history
- Contraindication for Computed Tomography Angiography according the standard daily clinical routine
Design
Recruitment
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 | NL42743.041.12 |
| Other | nnb |