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

NCT02196753 | Unknown

• 1 other identifier: 2.32/V/2014
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Complications; Infective Endocarditis; Implant Site Pocket Infection; Fever of Unknown Origin

Keywords

Positron emission tomography combined with computed tomography; PET CT; Cardiovascular Implantable Electronic Device; Infective endocarditis; Generator pocket infection; Fever of unknown origin

Outcome Measures

Primary Outcomes (1)

• Number of participants with established diagnosis

  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

  up to 6 months

Secondary Outcomes (4)

• Number of participants with remote infective complications

  up to 6 months

• Number of participants with particular localizations of infection

  up to 6 months

• Number of participants with sustained therapuetic decision

  up to 6 months

• Number of participants with complications of PET CT

  up to 6 months

Study Arms (2)

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

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

Interventions

PET CT OTHER

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.

Also known as: Positron emission tomography - computed tomography

CIED related infection; Non-infective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

Institute of Cardiology, II Dept. of Coronary Heart Disease

Warsaw, Masovian Voivodeship, 02-637, Poland

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Endocarditis; Fever of Unknown Origin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Fever; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maciej Sterliński, MD, PhD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

• Hanna Szwed, MD, PhD

  National Institute of Cardiology, Warsaw, Poland

  STUDY CHAIR

Central Study Contacts

Maciej Sterliński, MD, PhD

CONTACT

223434050; msterlinski@poczta.onet.pl

Marta B Marciniak, MD

CONTACT

223434050; mmarciniak@ikard.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: July 22, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

PL (1)