<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02196753</url>
  </required_header>
  <id_info>
    <org_study_id>2.32/V/2014</org_study_id>
    <nct_id>NCT02196753</nct_id>
  </id_info>
  <brief_title>PET CT in Suspected CIED Infection, a Pilot Study - PET Guidance I</brief_title>
  <acronym>PET Guidance I</acronym>
  <official_title>Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiovascular Implantable Electronic Device Infection, a Pilot Study - PET Guidance I</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Cardiology, Warsaw, Poland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Cardiology, Warsaw, Poland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this single-center randomized controlled trial is to assess clinical usefulness of&#xD;
      positron emission tomography combined with computed tomography (PET CT) in the diagnostic&#xD;
      process of suspected cardiovascular implantable electronic device (CIED) infection (lead&#xD;
      dependent infective endocarditis, generator pocket infection, fever of unknown origin).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular implantable electronic device (CIED) infection is a complication of increasing&#xD;
      incidence. The prevalence of CIED infection is estimated at 2%, with differences between&#xD;
      authors ranging from 0.13% to 19.9%.&#xD;
&#xD;
      According to European Heart Rhythm Association survey conducted in high volume centers&#xD;
      prevalence of CIED infections was below 2%. The majority of centers were able to isolate the&#xD;
      infectious agent in ≤50% of blood cultures which underscore the difficulty in finding the&#xD;
      agent of CIEDs infection in many cases.&#xD;
&#xD;
      Cardiovascular implantable device infections can be categorized into 3 groups: superficial&#xD;
      skin infection, generator pocket infection and intravascular infection with intact generator&#xD;
      pocket. Although local pocket infection is the most common clinical infection occurring early&#xD;
      after implantation, positive blood cultures may be the only sign of late onset intravascular&#xD;
      infection Mortality in cardiovascular implantable electronic device related infective&#xD;
      endocarditis treated with antibiotics only reaches 66%, whereas with combined therapy&#xD;
      (antibiotics and complete device removal) it is 3-fold lower.&#xD;
&#xD;
      Prolonged targeted antibiotic therapy (4 to 6 weeks) with complete device removal and&#xD;
      revision of indications for re-implantation is recommended in most cases (class I with&#xD;
      confirmed diagnosis and IIa with probable diagnosis).&#xD;
&#xD;
      In complicated and uncertain cases additional diagnostic tools are needed, especially if we&#xD;
      take into account the load of the patient associated with device removal, prolonged&#xD;
      hospitalization and re-implantation.&#xD;
&#xD;
      Apart from morbidity and mortality, infections are also associated with significant financial&#xD;
      cost for patients and third-party payers. Polish data on this issue are not available yet but&#xD;
      in US the estimated average cost of combined medical and surgical treatment of CIED-related&#xD;
      infection ranges from USD 25,000 for permanent pacemakers to USD 50,000 for implantable&#xD;
      cardioverter-defibrillators.&#xD;
&#xD;
      Positron emission tomography combined with computed tomography (PET CT) can play an important&#xD;
      role in difficult cases of CIED-related infections but published studies focused on the&#xD;
      outcomes and safety of this procedure only briefly considering the economical aspect of this&#xD;
      diagnostic test.&#xD;
&#xD;
      Recent studies show that PET CT scan is effective and precise tool that can facilitate&#xD;
      diagnostic process and decision making regarding therapy especially in difficult patients&#xD;
      with CIED-related infections. PET CT scan can protect patients from unnecessary device&#xD;
      removal or from too late removal. PET CT may also help in diagnosing other sources of&#xD;
      infection, embolic complications, neoplasms, autoimmune diseases and connective tissue&#xD;
      diseases.&#xD;
&#xD;
      However there are some issues concerning low sensitivity connected with elevated marker&#xD;
      uptake in myocardium and in case of small vegetations, especially lead-related In most&#xD;
      studies assessing PET CT in diagnostic process of CIED related infections standard oncologic&#xD;
      protocols were used. Those protocols may not be optimal to assess FDG uptake by inflammatory&#xD;
      cells.&#xD;
&#xD;
      The aim of this single-center randomized controlled trial is to assess clinical usefulness of&#xD;
      positron emission tomography combined with computed tomography (PET CT) in the diagnostic&#xD;
      process of suspected cardiovascular implantable electronic device (CIED) infection (lead&#xD;
      dependent infective endocarditis, generator pocket infection, fever of unknown origin).&#xD;
&#xD;
      All patients participating in the study will undergo standard diagnostic process.&#xD;
      Conventional/standard diagnostic and therapeutic process will consist of: medical interview,&#xD;
      physical examination, laboratory tests, blood cultures (3 sets, 1 hour apart, repeated after&#xD;
      24 hours and -if applicable - with fever peak above 38°C); imaging studies (echocardiography:&#xD;
      transthoracic, and if there are no contraindications transesophageal, in case of negative or&#xD;
      equivocal result repeated after 7-10 days, or in series if necessary, computed tomography&#xD;
      scan for pulmonary embolism if indicated); if there are abnormalities in other systems,&#xD;
      decisions concerning further diagnostics will be made by the physician in charge.&#xD;
&#xD;
      Apart from standard diagnostic procedures patients will undergo whole body PET CT scan to&#xD;
      localize infection or inflammation.&#xD;
&#xD;
      Then the investigators team will make a decision concerning further treatment (antibiotics&#xD;
      and complete device removal vs conservative treatment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with established diagnosis</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Standardization of PET CT in diagnostic process of local infections and lead dependent endocarditis in clinical practice. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of the diagnosis held by PET CT compared with final clinical diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with remote infective complications</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with particular localizations of infection</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Incidence of particular localizations of infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with sustained therapuetic decision</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT (percentage)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with complications of PET CT</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Safety and complications of diagnostic process of CIED related infections with PET CT</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Complications</condition>
  <condition>Infective Endocarditis</condition>
  <condition>Implant Site Pocket Infection</condition>
  <condition>Fever of Unknown Origin</condition>
  <arm_group>
    <arm_group_label>CIED related infection</arm_group_label>
    <description>All patients will undergo standard diagnostic process that will consist of: medical interview, physical examination, laboratory tests, blood cultures (3 sets, 1 hour apart, repeated after 24 hours and -if applicable - with fever peak above 38°C); imaging studies (echocardiography: transthoracic, and if there are no contraindications transesophageal, in case of negative or equivocal result repeated after 7-10 days, or in series if necessary, computed tomography scan for pulmonary embolism if indicated); if there are abnormalities in other systems, decisions concerning further diagnostics will be made by the physician in charge.&#xD;
Apart from standard diagnostic procedures patients will undergo whole body PET CT scan to localize infection or inflammation.&#xD;
Then the investigators team will make a decision concerning further treatment (antibiotics and complete device removal vs conservative treatment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-infective</arm_group_label>
    <description>Control group consisting of 20 pts with implanted CIEDs who underwent PET CT due to non infectious indications and have no data for infectious process in follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PET CT</intervention_name>
    <description>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.&#xD;
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&gt; 40% of the background.</description>
    <arm_group_label>CIED related infection</arm_group_label>
    <arm_group_label>Non-infective</arm_group_label>
    <other_name>Positron emission tomography - computed tomography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study group - twenty pts with implanted CIEDs and suspected or diagnosed CIED-related&#xD;
        infection or fever of unknown origin.&#xD;
&#xD;
        Control group - twenty pts with implanted CIEDs who underwent PET CT due to non infectious&#xD;
        indications and have no data for infectious process in follow-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age - 18 years and older.&#xD;
&#xD;
          -  Written informed consent for participating in the study and written standard version&#xD;
             of informed consent for PET CT scan.&#xD;
&#xD;
          -  Suspected generator pocket infection&#xD;
&#xD;
          -  Suspected cardiovascular implantable electronic device (CIED)-related infective&#xD;
             endocarditis&#xD;
&#xD;
          -  Fever of unknown origin in patient with CIED&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of written informed consent&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Inability to stay supine for the time of PET CT scan&#xD;
&#xD;
          -  Unstable cardio-pulmonary state&#xD;
&#xD;
          -  Glucose level above 200 mg/dl&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maciej Sterliński, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Cardiology, Warsaw, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanna Szwed, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>National Institute of Cardiology, Warsaw, Poland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maciej Sterliński, MD, PhD</last_name>
    <phone>223434050</phone>
    <phone_ext>+48</phone_ext>
    <email>msterlinski@poczta.onet.pl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marta B Marciniak, MD</last_name>
    <phone>223434050</phone>
    <phone_ext>+48</phone_ext>
    <email>mmarciniak@ikard.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Cardiology, II Dept. of Coronary Heart Disease</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>02-637</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marta Marciniak, MD</last_name>
      <phone>223434050</phone>
      <phone_ext>+48</phone_ext>
      <email>mmarciniak@ikard.pl</email>
    </contact>
    <contact_backup>
      <last_name>Maciej Sterliński, MD, PhD</last_name>
      <phone>223434050</phone>
      <phone_ext>+48</phone_ext>
      <email>msterlinski@poczta.onet.pl</email>
    </contact_backup>
    <investigator>
      <last_name>Marta B Marciniak, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maciej Sterliński, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aleksander Maciąg, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bohdan Firek, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paweł Syska, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michał Farkowski, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hanna Szwed, Md, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mariusz Pytkowski, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mirosław Dziuk, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Baddour LM, Epstein AE, Erickson CC, Knight BP, Levison ME, Lockhart PB, Masoudi FA, Okum EJ, Wilson WR, Beerman LB, Bolger AF, Estes NA 3rd, Gewitz M, Newburger JW, Schron EB, Taubert KA; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; Council on Cardiovascular Disease in Young; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Nursing; Council on Clinical Cardiology; Interdisciplinary Council on Quality of Care; American Heart Association. Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the American Heart Association. Circulation. 2010 Jan 26;121(3):458-77. doi: 10.1161/CIRCULATIONAHA.109.192665. Epub 2010 Jan 4.</citation>
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    <citation>Klug D, Balde M, Pavin D, Hidden-Lucet F, Clementy J, Sadoul N, Rey JL, Lande G, Lazarus A, Victor J, Barnay C, Grandbastien B, Kacet S; PEOPLE Study Group. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation. 2007 Sep 18;116(12):1349-55. doi: 10.1161/CIRCULATIONAHA.106.678664. Epub 2007 Aug 27.</citation>
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    <citation>Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.</citation>
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    <citation>Cabell CH, Heidenreich PA, Chu VH, Moore CM, Stryjewski ME, Corey GR, Fowler VG Jr. Increasing rates of cardiac device infections among Medicare beneficiaries: 1990-1999. Am Heart J. 2004 Apr;147(4):582-6. doi: 10.1016/j.ahj.2003.06.005.</citation>
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    <citation>Bongiorni MG, Marinskis G, Lip GY, Svendsen JH, Dobreanu D, Blomstrom-Lundqvist C; Scientific Initiative Committee, European Heart Rhythm Association. How European centres diagnose, treat, and prevent CIED infections: results of an European Heart Rhythm Association survey. Europace. 2012 Nov;14(11):1666-9. doi: 10.1093/europace/eus350.</citation>
    <PMID>23104858</PMID>
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  <reference>
    <citation>Dababneh AS, Sohail MR. Cardiovascular implantable electronic device infection: a stepwise approach to diagnosis and management. Cleve Clin J Med. 2011 Aug;78(8):529-37. doi: 10.3949/ccjm.78a.10169.</citation>
    <PMID>21807925</PMID>
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    <citation>Habib G, Hoen B, Tornos P, Thuny F, Prendergast B, Vilacosta I, Moreillon P, de Jesus Antunes M, Thilen U, Lekakis J, Lengyel M, Muller L, Naber CK, Nihoyannopoulos P, Moritz A, Zamorano JL; ESC Committee for Practice Guidelines. Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (new version 2009): the Task Force on the Prevention, Diagnosis, and Treatment of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the International Society of Chemotherapy (ISC) for Infection and Cancer. Eur Heart J. 2009 Oct;30(19):2369-413. doi: 10.1093/eurheartj/ehp285. Epub 2009 Aug 27. No abstract available.</citation>
    <PMID>19713420</PMID>
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    <citation>Darouiche RO. Treatment of infections associated with surgical implants. N Engl J Med. 2004 Apr 1;350(14):1422-9. doi: 10.1056/NEJMra035415. No abstract available.</citation>
    <PMID>15070792</PMID>
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    <citation>Ferguson TB Jr, Ferguson CL, Crites K, Crimmins-Reda P. The additional hospital costs generated in the management of complications of pacemaker and defibrillator implantations. J Thorac Cardiovasc Surg. 1996 Apr;111(4):742-51;discussion 751-2. doi: 10.1016/s0022-5223(96)70334-3.</citation>
    <PMID>8614134</PMID>
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    <citation>Farkowski MM, Milkowski M, Dziuk M, Pytkowski M, Marciniak M, Kraska A, Szwed H, Sterlinski M. Economical aspect of PET/CT-guided diagnosis of suspected infective endocarditis in a patient with implantable cardioverter-defibrillator. Heart Lung. 2014 Jul-Aug;43(4):341-3. doi: 10.1016/j.hrtlng.2014.04.002. Epub 2014 May 22.</citation>
    <PMID>24856231</PMID>
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    <citation>Sarrazin JF, Philippon F, Tessier M, Guimond J, Molin F, Champagne J, Nault I, Blier L, Nadeau M, Charbonneau L, Trottier M, O'Hara G. Usefulness of fluorine-18 positron emission tomography/computed tomography for identification of cardiovascular implantable electronic device infections. J Am Coll Cardiol. 2012 May 1;59(18):1616-25. doi: 10.1016/j.jacc.2011.11.059.</citation>
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    <citation>Ploux S, Riviere A, Amraoui S, Whinnett Z, Barandon L, Lafitte S, Ritter P, Papaioannou G, Clementy J, Jais P, Bordenave L, Haissaguerre M, Bordachar P. Positron emission tomography in patients with suspected pacing system infections may play a critical role in difficult cases. Heart Rhythm. 2011 Sep;8(9):1478-81. doi: 10.1016/j.hrthm.2011.03.062. Epub 2011 Apr 2.</citation>
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    <citation>Bensimhon L, Lavergne T, Hugonnet F, Mainardi JL, Latremouille C, Maunoury C, Lepillier A, Le Heuzey JY, Faraggi M. Whole body [(18) F]fluorodeoxyglucose positron emission tomography imaging for the diagnosis of pacemaker or implantable cardioverter defibrillator infection: a preliminary prospective study. Clin Microbiol Infect. 2011 Jun;17(6):836-44. doi: 10.1111/j.1469-0691.2010.03312.x. Epub 2010 Jul 15.</citation>
    <PMID>20636421</PMID>
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    <citation>Cautela J, Alessandrini S, Cammilleri S, Giorgi R, Richet H, Casalta JP, Habib G, Raoult D, Mundler O, Deharo JC. Diagnostic yield of FDG positron-emission tomography/computed tomography in patients with CEID infection: a pilot study. Europace. 2013 Feb;15(2):252-7. doi: 10.1093/europace/eus335. Epub 2012 Nov 12.</citation>
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    <citation>Leccisotti L, Perna F, Lago M, Leo M, Stefanelli A, Calcagni ML, Pelargonio G, Narducci ML, Bencardino G, Bellocci F, Giordano A. Cardiovascular implantable electronic device infection: delayed vs standard FDG PET-CT imaging. J Nucl Cardiol. 2014 Jun;21(3):622-32. doi: 10.1007/s12350-014-9896-2. Epub 2014 Apr 10.</citation>
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    <citation>Millar BC, Prendergast BD, Alavi A, Moore JE. 18FDG-positron emission tomography (PET) has a role to play in the diagnosis and therapy of infective endocarditis and cardiac device infection. Int J Cardiol. 2013 Sep 1;167(5):1724-36. doi: 10.1016/j.ijcard.2012.12.005. Epub 2013 Jan 11.</citation>
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  <verification_date>May 2015</verification_date>
  <study_first_submitted>June 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Positron emission tomography combined with computed tomography</keyword>
  <keyword>PET CT</keyword>
  <keyword>Cardiovascular Implantable Electronic Device</keyword>
  <keyword>Infective endocarditis</keyword>
  <keyword>Generator pocket infection</keyword>
  <keyword>Fever of unknown origin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Endocarditis, Bacterial</mesh_term>
    <mesh_term>Endocarditis</mesh_term>
    <mesh_term>Fever of Unknown Origin</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02196753
org study id: 2.32/V/2014
nct id: NCT02196753
lead sponsor: 
has dmc: No
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).
Cardiovascular implantable electronic device (CIED) infection is a complication of increasing
      incidence. The prevalence of CIED infection is estimated at 2%, with differences between
      authors ranging from 0.13% to 19.9%.

      According to European Heart Rhythm Association survey conducted in high volume centers
      prevalence of CIED infections was below 2%. The majority of centers were able to isolate the
      infectious agent in ≤50% of blood cultures which underscore the difficulty in finding the
      agent of CIEDs infection in many cases.

      Cardiovascular implantable device infections can be categorized into 3 groups: superficial
      skin infection, generator pocket infection and intravascular infection with intact generator
      pocket. Although local pocket infection is the most common clinical infection occurring early
      after implantation, positive blood cultures may be the only sign of late onset intravascular
      infection Mortality in cardiovascular implantable electronic device related infective
      endocarditis treated with antibiotics only reaches 66%, whereas with combined therapy
      (antibiotics and complete device removal) it is 3-fold lower.

      Prolonged targeted antibiotic therapy (4 to 6 weeks) with complete device removal and
      revision of indications for re-implantation is recommended in most cases (class I with
      confirmed diagnosis and IIa with probable diagnosis).

      In complicated and uncertain cases additional diagnostic tools are needed, especially if we
      take into account the load of the patient associated with device removal, prolonged
      hospitalization and re-implantation.

      Apart from morbidity and mortality, infections are also associated with significant financial
      cost for patients and third-party payers. Polish data on this issue are not available yet but
      in US the estimated average cost of combined medical and surgical treatment of CIED-related
      infection ranges from USD 25,000 for permanent pacemakers to USD 50,000 for implantable
      cardioverter-defibrillators.

      Positron emission tomography combined with computed tomography (PET CT) can play an important
      role in difficult cases of CIED-related infections but published studies focused on the
      outcomes and safety of this procedure only briefly considering the economical aspect of this
      diagnostic test.

      Recent studies show that PET CT scan is effective and precise tool that can facilitate
      diagnostic process and decision making regarding therapy especially in difficult patients
      with CIED-related infections. PET CT scan can protect patients from unnecessary device
      removal or from too late removal. PET CT may also help in diagnosing other sources of
      infection, embolic complications, neoplasms, autoimmune diseases and connective tissue
      diseases.

      However there are some issues concerning low sensitivity connected with elevated marker
      uptake in myocardium and in case of small vegetations, especially lead-related In most
      studies assessing PET CT in diagnostic process of CIED related infections standard oncologic
      protocols were used. Those protocols may not be optimal to assess FDG uptake by inflammatory
      cells.

      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).

      All patients participating 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 (3 sets, 1 hour apart, repeated after
      24 hours and -if applicable - with fever peak above 38°C); imaging studies (echocardiography:
      transthoracic, and if there are no contraindications transesophageal, in case of negative or
      equivocal result repeated after 7-10 days, or in series if necessary, computed tomography
      scan for pulmonary embolism if indicated); if there are abnormalities in other systems,
      decisions concerning further diagnostics will be made by the physician in charge.

      Apart from standard diagnostic procedures patients will undergo whole body PET CT scan to
      localize infection or inflammation.

      Then the investigators team will make a decision concerning further treatment (antibiotics
      and complete device removal vs conservative treatment).
observational model: Case-Control
time perspective: Prospective
measure: Number of participants with established diagnosis
time frame: up to 6 months
description: Standardization of PET CT in diagnostic process of local infections and lead dependent endocarditis in clinical practice. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of the diagnosis held by PET CT compared with final clinical diagnosis
measure: Number of participants with remote infective complications
time frame: up to 6 months
description: Assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli)
measure: Number of participants with particular localizations of infection
time frame: up to 6 months
description: Incidence of particular localizations of infection
measure: Number of participants with sustained therapuetic decision
time frame: up to 6 months
description: Influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT (percentage)
measure: Number of participants with complications of PET CT
time frame: up to 6 months
description: Safety and complications of diagnostic process of CIED related infections with PET CT
arm group label: CIED related infection
description: All patients will undergo standard diagnostic process that will consist of: medical interview, physical examination, laboratory tests, blood cultures (3 sets, 1 hour apart, repeated after 24 hours and -if applicable - with fever peak above 38°C); imaging studies (echocardiography: transthoracic, and if there are no contraindications transesophageal, in case of negative or equivocal result repeated after 7-10 days, or in series if necessary, computed tomography scan for pulmonary embolism if indicated); if there are abnormalities in other systems, decisions concerning further diagnostics will be made by the physician in charge.
Apart from standard diagnostic procedures patients will undergo whole body PET CT scan to localize infection or inflammation.
Then the investigators team will make a decision concerning further treatment (antibiotics and complete device removal vs conservative treatment).
arm group label: Non-infective
description: Control group consisting of 20 pts with implanted CIEDs who underwent PET CT due to non infectious indications and have no data for infectious process in follow-up
intervention type: Other
intervention name: PET CT
description: 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.
arm group label: CIED related infection
arm group label: Non-infective
other name: Positron emission tomography - computed tomography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maciej Sterliński, MD, PhD
role: Principal Investigator
affiliation: National Institute of Cardiology, Warsaw, Poland
last name: Hanna Szwed, MD, PhD
role: Study Chair
affiliation: National Institute of Cardiology, Warsaw, Poland
last name: Maciej Sterliński, MD, PhD
phone: 223434050
phone ext: +48
email: msterlinski@poczta.onet.pl
last name: Marta B Marciniak, MD
phone: 223434050
phone ext: +48
email: mmarciniak@ikard.pl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Poland
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responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Endocarditis, Bacterial
mesh term: Endocarditis
mesh term: Fever of Unknown Origin