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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 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: May 27, 2015
Last verified: May 2015
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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:
  • Number of participants with established diagnosis [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Number of participants with remote infective complications [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Incidence of particular localizations of infection

  • Number of participants with sustained therapuetic decision [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Safety and complications of diagnostic process of CIED related infections with PET CT


Estimated Enrollment: 40
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)
Groups/Cohorts Assigned Interventions
CIED related infection

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).

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.

Other Name: Positron emission tomography - computed tomography
Non-infective
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
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.

Other Name: Positron emission tomography - computed tomography

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study group - twenty pts with implanted CIEDs and suspected or diagnosed CIED-related infection or fever of unknown origin.

Control group - twenty pts with implanted CIEDs who underwent PET CT due to non infectious indications and have no data for infectious process in follow-up.

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
  • Glucose level above 200 mg/dl
  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: Maciej Sterliński, MD, PhD 223434050 ext +48 msterlinski@poczta.onet.pl
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   
Sub-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: Maciej Sterliński, MD, PhD Institute of Cardiology, Warsaw, Poland
Study Chair: Hanna Szwed, MD, PhD Institute of Cardiology, Warsaw, Poland
  More Information

Publications:

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: May 27, 2015
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:
Communicable Diseases
Endocarditis
Endocarditis, Bacterial
Fever of Unknown Origin
Infection
Bacterial Infections
Body Temperature Changes
Cardiovascular Diseases
Cardiovascular Infections
Fever
Heart Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 01, 2015