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Diagnostic Accuracy of 18FDG-PET-CT for Pacing or Defibrillation Lead Infection (ENDOTEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02251262
Recruitment Status : Unknown
Verified January 2017 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : September 29, 2014
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. The diagnosis is evident in presence of an abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to the lead. On the other hand, a proportion of patients present with less specific clinical manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious disorder of unknown origin despite detailed investigations. Without proof of lead infection, removal of the system without confirmation of its infection is usually proposed, despite the known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive culture of the leads implies that the leads were involved in the infectious process. In recent years, 18FDG-PET-CT scan has made promising contributions in different areas including imaging to detect infection at different organ sites. Absence of hyperfixation of the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system infection.

The extraction of intracardiac implanted material, when it is indicated by the current standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients, even when they did not receive antibiotics before extraction.

The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current strategy may avoid or reduce these false-positives.

Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its sensitivity.

For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit; secondarily, an intervention for the extraction of the intra-cardiac material, under general anesthesia, will be practiced and then a bacteriological culture for extracted material will be required.

The end of study visit is complete the last day of material extraction. The follow up will last 2 to 7 days.

Condition or disease Intervention/treatment Phase
Infections of the Implanted Material Endocarditis Device: Whole-body 18FDG-PET-CT scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Assessment of Diagnostic Accuracy of 18FDG-PET-CT in Patients With Suspicion of Pacing or Defibrillation Lead Infection: a Prospective Multi-center Study
Actual Study Start Date : June 22, 2015
Estimated Primary Completion Date : June 22, 2017
Estimated Study Completion Date : June 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: Whole-body 18FDG-PET-CT scan
18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.
Device: Whole-body 18FDG-PET-CT scan
18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.

Primary Outcome Measures :
  1. A semi-quantitative visual interpretation of 18FDG-PET-CT in the diagnosis of infection of intracardiac device. [ Time Frame: up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy) ]

    Index tests will be interpreted by nuclear medicine physician from the center where the patient was included with a semi-quantitative visual score.

    Moreover, all 18FDG-PET-CT recordings will be sent to the coordinating center for centralized interpretation blind to the preceding one.

    All 18FDG-PET-CT recordings will be stored until interpretation, and not used for the clinical management of the patient.

    Index test interpretations will be carried out blind to any other information on the patient (clinical, biology,…).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Both genders
  • Age > 18 years
  • Patient referred for extraction of cardiac material (box and lead(s)) in the context of suspicion of material infection, including a patient with pocket infection.
  • Possibility of carrying out PET-CT no more than 48 hours before extraction (or, exceptionally, no more than 7 days if the patient is not under antibiotic therapy).
  • Informed written consent
  • Affiliation to a social security system

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patients with recent implantation (less than 2 months)
  • Subjects placed under judicial protection
  • Subjects participating in another study that includes an exclusion period on-going at the time of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02251262

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Contact: Pierre BORDACHAR, MD
Contact: Elodie SERIS

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CHU de Grenoble - Hôpital A. Michallon Recruiting
Grenoble, France, 38043
Contact: Pascal DEFAYE, MD   
Sub-Investigator: Daniel FAGRET, MD         
Principal Investigator: Pascal DEFAYE, MD         
CHRU de Lille - Hôpital R. Salengro Recruiting
Lille, France, 59037
Contact: Didier KLUG, MD   
Principal Investigator: Didier KLUG, MD         
Sub-Investigator: Claude HOSSEIN-FOUCHER, MD         
AP-HM - Hôpital La Timone Recruiting
Marseille, France, 13385
Contact: Jean-Claude DEHARO, MD   
Principal Investigator: Jean-Claude DEHARO, MD         
Sub-Investigator: Olivier MUNDLER, MD         
CHU de Bordeaux Recruiting
Pessac, France, 33604
Contact: Pierre BORDACHAR, MD   
Contact: Elodie SERIS   
Principal Investigator: Pierre BORDACHAR, MD         
Sub-Investigator: Laurence BORDENAVE, MD         
Sub-Investigator: Ghoufrane TLILI, MD         
Sub-Investigator: Olivia PEUCHANT, MD         
Clinique Pasteur Recruiting
Toulouse, France, 31076
Contact: Serge BOVEDA, MD   
Principal Investigator: Serge BOVEDA, MD         
Sub-Investigator: Eric BULLIER, MD         
CHU de Nancy - Hôpital de Brabois Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: Nicolas SADOUL, MD   
Principal Investigator: Nicolas SADOUL, MD         
Sub-Investigator: Pierre-Yves MARIE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Pierre BORDACHAR, MD University Hospital, Bordeaux
Study Chair: Paul PEREZ, MD, PhD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux Identifier: NCT02251262     History of Changes
Other Study ID Numbers: CHUBX 2013/31
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by University Hospital, Bordeaux:
Diagnostic accuracy
Pacing or defibrillation lead

Additional relevant MeSH terms:
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Communicable Diseases
Heart Diseases
Cardiovascular Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action