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Fusie van cardiale CT en PET scan voor bepalen van normale glucose (suiker) opname rondom een Aorta Kunstklep

Fusion of Cardiac Computed Tomography Angiography (CTA) and 18F-Fluorodesoxyglucose Positron Emission Tomography (FDG-PET) to Determine Normal Peri-annular FDG Uptake after Aortic Valve Implantation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24441
Enrollment
75
Registered
2016-06-14
Start date
2013-05-21
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PET-CT, CTA, prosthetic heart valve, endocarditis

Interventions

PET-CT and CTA

Sponsors

University Medical Center Utrecht, Erasmus Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age &#8805; 50 years Patients after uncomplicated PHV implantation in aortic position (mechanical and biological PHVs). Normal routine follow up TTE (standardly performed 5 days after operation). With no signs of obstruction, endocarditis or significant paravalvular leakages. Group 1: 5 (± 1) weeks after PHV implantation (n=25). Group 2: 12 (± 2) weeks after PHV implantation (n=25). Group 3 : 12 (± 2) months after PHV implantation (n=25). Inclusion in group 3: only in case of &#8805; 1 patients with post-operative moderate/severe uptake (QVSH score) in group 2. Weight < 110 kg

Exclusion criteria

Exclusion criteria: Known contrast allergy Known renal impairment (GFR<60) Diabetes Mellitus Mild contractile dysfunction of the left and/or right ventrical (Eyeballing, Ejection fraction <45 %, TAPSE <14 mm) Active cardiac decompensation Uncontrolled cardiac arrhythmias Suspicion on active endocarditis Previous participation in scientific studies using radiation. (Possible) pregnancy in pre-menopausal women above 50 years not on reliable birth control therapy. Other contraindications for contrast use according the standard daily clinical routine according to the protocol “Protocol preventie contrastreactie en contrastnefropathie” by the department of radiology UMCU or EMC 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 Refusal to be informed about potential additional CTA or FDG-PET findings If already included in group 1 (early post operative phase), patients cannot be included in group 2 or 3 (late post operative phase).

Design outcomes

Primary

MeasureTime frame
- Qualification Visual Score for Hypermetabolism (QVSH) - Standardized Uptake Value (SUV) ratio (quantitative measurement)

Secondary

MeasureTime frame
- 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

Contacts

Public ContactA.M. Harder, den

University Medical Center Utrecht, Department of Radiology P.O. Box 85500, E01.132

A.M.denHarder-4@umcutrecht.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)