New diagnostic pathways urgently needed. Protocol of PET Guidance I pilot study: Positron Emission Tomography in suspected XXXX .

@entity1 @entity32 @entity2286 @entity1151 @entity281 @entity299 @entity884
BACKGROUND: Cardiac implantable electronic device (CIED) @entity281 is a complication of increasing incidence. We present a protocol of an observational case control clinical trial "Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiac Implantable Electronic Device Infection, a Pilot Study - PET Guidance I" (NCT02196753). AIM: The aim of this observational clinical trial is to assess and standardize diagnostic algorithmsforCardiovascular Implantable Electronic Device (CIED) @entity281 (lead dependent @entity884 , generator pocket @entity281 , fever of unknown origin) with PET CT in Poland. METHODS AND RESULTS: Study group will consist of 20 pts with initial diagnosis of @entity299 paired with control group of 20 pts with implanted CIEDs who underwent PET CT due to other non infectious indications and have no data for infectious process in follow-up. All @entity1 included in the study will undergo standard diagnostic process. Conventional/standard diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, blood cultures; imaging studies: echocardiography: transthoracic (TTE), and if there are no contraindications transesophageal, computed tomography scan for @entity1151 if indicated; if there are abnormalities in other systems, decisions concerning further diagnostics will be made on physician discretion. Apart from standard diagnostic procedures @entity1 will undergo whole body PET CT scan to @entity281 or @entity32 . Diagnosis and therapeutic decision will be obtained from the Study Committee. Follow-up will be held within 6 months with control visits at 3 and 6 month. During each follow-up visit, all @entity1 will undergo laboratory tests, 2 blood cultures collected 1 hr apart, and echocardiography (TTE). In case of actual clinical suspicion of @entity884 or local generator pocket @entity281 all @entity1 will be referred for further diagnostics. Endpoints for the results assessment: Primary endpoints are to standardise PET CT in diagnostic process: sensitivity, specificity, positive predictive value ( @entity2286 ), negative predictive value (NPV) of the diagnosis made by PET CT. Secondary endpoints are: assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, @entity1151 ), incidence of particular localizations of @entity281 , influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT, safety and complications of diagnostic process of CIED related @entity281 with PET CT. CONCLUSIONS: Evaluation of positron emission computed tomography use for device-related @entity281 in a case control study may be conclusive and improve diagnostic pathway.
