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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiovascular Implantable Electronic Device Infection, a Pilot Study - PET Guidance I

Brief 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).

Detailed Summary:

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-p
Sponsor: Institute of Cardiology, Warsaw, Poland

Current Primary Outcome: Number of participants with established diagnosis [ Time Frame: up to 6 months ]

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


Original Primary Outcome: Time to diagnosis [ Time Frame: up to 6 months ]

To determine the influence of the diagnostic strategy (PET CT vs conventional diagnostic process according to appropriate guidelines and rules of good clinical practice) on the time to establishing diagnosis or final decision regarding treatment


Current Secondary Outcome:

  • Number of participants with remote infective complications [ Time Frame: up to 6 months ]
    Assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli)
  • Number of participants with particular localizations of infection [ Time Frame: up to 6 months ]
    Incidence of particular localizations of infection
  • Number of participants with sustained therapuetic decision [ Time Frame: up to 6 months ]
    Influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT (percentage)
  • Number of participants with complications of PET CT [ Time Frame: up to 6 months ]
    Safety and complications of diagnostic process of CIED related infections with PET CT


Original Secondary Outcome:

  • Cost-effectiveness of the chosen diagnostic strategy [ Time Frame: 6 months ]

    Establishing cost-effectiveness of the chosen diagnostic strategy

    • Hospitalization time
    • Number of the removed CIED systems
  • Number of participants with adverse events [ Time Frame: up to 6 months ]

    To determine the influence of the diagnostic strategy (PET CT vs conventional diagnostic process according to appropriate guidelines and rules of good clinical practice) on the incidence of adverse events connected with:

    • diagnostic process
    • pharmacotherapy
    • invasive treatment
  • Number of participants with complications of infective endocarditis [ Time Frame: up to 6 months ]

    To determine the influence of the diagnostic strategy (PET CT vs conventional diagnostic process according to appropriate guidelines and rules of good clinical practice) on establishing the diagnosis of complications of infective endocarditis

    • evaluation of ejection fraction and valve function
    • evaluation of renal function
    • incidence of septic emboli
    • incidence of arterial emboli
    • Incidence of neurological complications
  • Number of participants with "clinical" endpoints [ Time Frame: 6 months ]
    To determine the influence of the diagnostic strategy (PET CT vs conventional diagnostic process according to current guidelines and rules of good clinical practice) on the incidence of "clinical" endpoints: death, cardiovascular death, cardiovascular hospitalization, stroke/transient ischemic attack (TIA), composite endpoint, consisting of: death, exacerbation of the heart failure.
  • Number of participants with established diagnosis [ Time Frame: up to 6 months ]

    To determine the influence of the diagnostic strategy (PET CT vs conventional diagnostic process according to appropriate guidelines and rules of good clinical practice) on establishing a diagnosis (lead-dependant infective endocarditis, generator pocket infection, superficial skin infection).

    • sensitivity, specificity , positive predictive value (PPV), negative predictive value (NPV)



Information By: Institute of Cardiology, Warsaw, Poland

Dates:
Date Received: June 13, 2014
Date Started: March 2014
Date Completion: March 2017
Last Updated: May 27, 2015
Last Verified: May 2015