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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Institute of Cardiology, Warsaw, Poland
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT02196753
First received: June 13, 2014
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Complications
Infective Endocarditis
Implant Site Pocket Infection
Fever of Unknown Origin
Other: PET CT
Other: Conventional diagnostic and therapeutic process

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiovascular Implantable Electronic Device Infection, a Pilot Study - PET Guidance I

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Time to diagnosis [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Cost-effectiveness of the chosen diagnostic strategy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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)



Other Outcome Measures:
  • Identification of predictive factors for lead-dependant infective endocarditis [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Identification of predictive factors for lead-dependant infective endocarditis using univariate logistic regression and then multivariate logistic regression analysis of gathered data (demographic and device-related variables, comorbid conditions and clinical features at presentation).

  • Costs of diagnostics and treatment [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

    Economic analyses (piggy-back trial) of utilization of PET CT in suspected cardiovascular implantable electronic device infection

    • 1st analysis: from the perspective of a hospital - impact of PET CT on intra-hospital costs of diagnostics and treatment of a patient with suspected CIED-related infection
    • 2nd analysis: from the perspective of the National Health Fund - impact of PET CT on extra-hospital costs of diagnostics and treatment of a patient with suspected CIED-related infection


Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET CT

All patients included in the study will undergo diagnostic process including: blood culture (3 sets, 1 hr apart), repeated after 24 hr; smear and culture from nose, pharynx, pocket; laboratory signs of infection (leukocytosis, ESR, CRP, PCT); echocardiography (transthoracic, and if there are no contraindications transesophageal).

Then depending on the result of echocardiography they will be assigned to appropriate groups.

Patients with negative or equivocal echocardiography assigned to intervention group, in which apart from standard diagnostic and therapeutic procedures, within 48-72 hrs from admission patients will undergo whole body PET CT scan to localize infection or inflammation.

Other: PET CT

All patients are examined by a physician before PET CT and if there are no contraindications they are given isotope intravenously. Studies are performed with 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG). The dose of 18F-FDG depends on patient`s weight and varies from 270 to 420 megabecquerel (MBq). Isotope uptake time is about 45 minutes. First CT scan lasting 2 min is performed followed by the PET scan lasting about 20 min. Usually area from mid thigh to eye level is scanned.

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.

Other Name: Positron emission tomography combined with computed tomography
Other: Conventional diagnostic and therapeutic process

Conventional diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, microbiological tests, imaging.

Decisions concerning further diagnostics will be made by the physician in charge.

Decisions concerning treatment (antibiotics and complete device removal vs conservative treatment) will be made by the investigators team.

Other Name: Standard diagnostic and therapeutic process
Conventional
Patients with negative or equivocal echocardiography assigned to control group, where diagnostic and therapeutic process will -be conducted in conventional way, according to appropriate guidelines - Conventional diagnostic and therapeutic process.
Other: Conventional diagnostic and therapeutic process

Conventional diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, microbiological tests, imaging.

Decisions concerning further diagnostics will be made by the physician in charge.

Decisions concerning treatment (antibiotics and complete device removal vs conservative treatment) will be made by the investigators team.

Other Name: Standard diagnostic and therapeutic process
Additional Control
Patients with positive echocardiography for infective endocarditis or evident generator pocket infection will be assigned to an additional control group in which diagnostic and therapeutic process will be conducted in conventional way, according to appropriate guidelines - Conventional diagnostic and therapeutic process.
Other: Conventional diagnostic and therapeutic process

Conventional diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, microbiological tests, imaging.

Decisions concerning further diagnostics will be made by the physician in charge.

Decisions concerning treatment (antibiotics and complete device removal vs conservative treatment) will be made by the investigators team.

Other Name: Standard diagnostic and therapeutic process

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age - 18 years and older.
  • Written informed consent for participating in the study and written standard version of informed consent for PET CT scan.
  • Suspected generator pocket infection
  • Suspected cardiovascular implantable electronic device (CIED)-related infective endocarditis
  • Fever of unknown origin in patient with CIED

Exclusion Criteria:

  • Lack of written informed consent
  • Pregnancy or breast feeding
  • Inability to stay supine for the time of PET CT scan
  • Unstable cardio-pulmonary state
  • Participation in other study at the time of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02196753

Contacts
Contact: Marta B Marciniak, MD 223434050 ext +48 mmarciniak@ikard.pl

Locations
Poland
Institute of Cardiology, II Dept. of Coronary Heart Disease Recruiting
Warsaw, Mazowieckie, Poland, 02-637
Contact: Marta Marciniak, MD    223434050 ext +48    mmarciniak@ikard.pl   
Contact: Maciej Sterliński, MD, PhD    223434050 ext +48    msterlinski@poczta.onet.pl   
Principal Investigator: Marta B Marciniak, MD         
Principal Investigator: Maciej Sterliński, MD, PhD         
Sub-Investigator: Aleksander Maciąg, MD, PhD         
Sub-Investigator: Bohdan Firek, MD, PhD         
Sub-Investigator: Paweł Syska, MD         
Sub-Investigator: Michał Farkowski, MD         
Sub-Investigator: Hanna Szwed, Md, PhD         
Sub-Investigator: Mariusz Pytkowski, MD, PhD         
Sub-Investigator: Mirosław Dziuk, MD, PhD         
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Principal Investigator: Marta B Marciniak, MD Institute of Cardiology, Warsaw, Poland
Study Chair: Maciej Sterliński, MD, PhD Institute of Cardiology, Warsaw, Poland
Study Chair: Hanna Szwed, MD, PhD Institute of Cardiology, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02196753     History of Changes
Other Study ID Numbers: 2.32/V/2014
Study First Received: June 13, 2014
Last Updated: July 18, 2014
Health Authority: Poland: The Central Register of Clinical Trials

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Positron emission tomography combined with computed tomography
PET CT
Cardiovascular Implantable Electronic Device
Infective endocarditis
Generator pocket infection
Fever of unknown origin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Endocarditis
Endocarditis, Bacterial
Fever of Unknown Origin
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Fever
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014