Centre de recherche de L'Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
NCT Number: NCT03683355
Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer (18F-FDG) uptake in noninfected transcatheter heart valves in early follow-up after transcatheter aortic valve replacement (TAVR).
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Notify Me18 year and older
All sexes
Observational
Québec, Quebec, G1V 4G5, Canada
Diagnostic accuracy of Infective endocarditis (IE) is commonly challenging. Current clinical guidelines recommend the use of the modified Duke criteria, based on clinical, echocardiographic and biological findings, as well as the results of blood cultures and serologies. Advances in imaging techniques have resulted in an improvement in the identification of endocardial involvements and extracardiac complications of IE. Thus, recent works have demonstrated that 18F-FDG PET/CT and radiolabeled leucocyte SPECT/CT may improve the detection of silent endocardial lesions. The sites of radiotracer accumulation show regions of a high metabolic activity due to an inflammation or infection process. It is well known that, in surgical prosthetic valves, a mild radiotracer uptake in the perivalvular area may occur in the absence of infection and could therefore be considered as a normal pattern, particularly early after valve replacement. However, evidence of this phenomenon is lacking regarding transcatheter heart valves and the factors used to distinguish between normal and abnormal patterns of radiolabeled tracer are not standardized. The hypothesis is that patients undergoing transcatheter aortic valve replacement (TAVR) show a radiolabeled tracer (18F-FDG) uptake around the prosthesis despite the absence of IE. Moreover, the uptake pattern might vary between different platforms.
Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer uptake in noninfected transcatheter heart valves in early follow-up after TAVR.
This will be a pilot study including 30 patients after TAVR procedure.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
18F-FDG PET/CT and blood cultures will be performed at 3-month follow-up after TAVR Patients with positive 18F-FDG PET/CT (moderate or intense radiolabeled tracer uptake) will be scheduled for a second 18F-FDG PET/CT at 6-month follow-up.
Time frame: 3 months after TAVR
Visual analysis grading the radiolabeled tracer molecules uptake in the prosthetic and periprosthetic areas as intense, moderate, mild or absent. This visual analysis will be defined whether the PET/CT was positive (intense/moderate) or negative (mild/absent).
Time frame: 3 months after TAVR
The intensity of the radiolabeled tracer uptake will be determined by measuring the maximal standardized uptake value (SUVmax)), which is obtained by normalizing the tissue concentration of the radiolabeled tracer activity and the patient's weight. SUVmax will be calculated using an average of 3 measurements from 3 volumes of interest (5mm3) introduced in the prosthetic region at equal distances from each other. The prosthetic valve-to-background ratio will be calculated by dividing the prosthetic valve SUV max by the atrial blood SUVmax.
Time frame: 3 months after TAVR
Differences in radiolabeled tracer uptake pattern with different valves: Edwards THV vs CoreValve THV
Time frame: 3 months after TAVR
Relationship between radiolabeled tracer uptake and time from the procedure
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Other
Characterization of Radiolabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves. The COUNT Study. A Prospective, Observational Study.
Acronym: COUNT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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