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PET CT in Suspected CIED Infection, a Pilot Study - PET Guidance I

NCT02196753 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2015-05-28

No results posted yet for this study

Summary

The aim of this single-center randomized controlled trial is to assess clinical usefulness of positron emission tomography combined with computed tomography (PET CT) in the diagnostic process of suspected cardiovascular implantable electronic device (CIED) infection (lead dependent infective endocarditis, generator pocket infection, fever of unknown origin).

Conditions

  • Complications
  • Infective Endocarditis
  • Implant Site Pocket Infection
  • Fever of Unknown Origin

Interventions

OTHER

PET CT

All patients are examined by a physicians before PET CT and if there are no contraindications they are given isotope intravenously. Then they stay in a warm waiting room. The dose of 18-FDG depends on patient's weight and varies from 270 to 420 MBq. Isotope uptake time is about 45-180 minutes. After that time the patient is asked to empty his or her bladder and go to the examination room. First CT scan lasting 2 min is performed followed by the PET scan lasting about 20 min. Usually area from mid tigh to eye level is scanned. In PET we use iterative reconstruction method (number of subsets 28, number of iterations 2), time of acquisition in one position of a table - 2 minutes. The following parameters will be analyzed: standardized uptake value (SUV) in the CIED area (pocket, leads), SUV of vascular background - pulmonary trunk, SUV of a liver, SUV max. in other potential changed areas, volume with increased SUV\> 40% of the background.

Sponsors & Collaborators

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Maciej Sterliński, MD, PhD · National Institute of Cardiology, Warsaw, Poland

  • Hanna Szwed, MD, PhD · National Institute of Cardiology, Warsaw, Poland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-09-30
Completion
2017-03-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196753 on ClinicalTrials.gov