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ComplicationsPET Guidance INCT02196753

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

An observational study of Complications and Infective Endocarditis, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PET CT
Type of treatment
Injection or infusion
How many people
40 participants
Where
1 sitePoland
Study dates
Mar 2014to Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Maciej Sterliński, MD, PhD contact

223434050 ext. +48

msterlinski@poczta.onet.pl

Marta B Marciniak, MD contact

223434050 ext. +48

mmarciniak@ikard.pl

Poland1 site, 1 recruiting

  • Institute of Cardiology, II Dept. of Coronary Heart Disease

    Warsaw, Masovian Voivodeship, 02-637

    Marta Marciniak, MD, 223434050 ext. +48, mmarciniak@ikard.pl

    Maciej Sterliński, MD, PhD, 223434050 ext. +48, msterlinski@poczta.onet.pl

    Recruiting

Other trials in Poland

About this study

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

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).

Read the detailed description

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-party payers. Polish data on this issue are not available yet but in US the estimated average cost of combined medical and surgical treatment of CIED-related infection ranges from USD 25,000 for permanent pacemakers to USD 50,000 for implantable cardioverter-defibrillators.

Positron emission tomography combined with computed tomography (PET CT) can play an important role in difficult cases of CIED-related infections but published studies focused on the outcomes and safety of this procedure only briefly considering the economical aspect of this diagnostic test.

Recent studies show that PET CT scan is effective and precise tool that can facilitate diagnostic process and decision making regarding therapy especially in difficult patients with CIED-related infections. PET CT scan can protect patients from unnecessary device removal or from too late removal. PET CT may also help in diagnosing other sources of infection, embolic complications, neoplasms, autoimmune diseases and connective tissue diseases.

However there are some issues concerning low sensitivity connected with elevated marker uptake in myocardium and in case of small vegetations, especially lead-related In most studies assessing PET CT in diagnostic process of CIED related infections standard oncologic protocols were used. Those protocols may not be optimal to assess FDG uptake by inflammatory cells.

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).

All patients participating in the study will undergo standard diagnostic process. Conventional/standard diagnostic and therapeutic process 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).

Being tested
PET CT
Keywords
Positron emission tomography combined with computed tomography, PET CT, Cardiovascular Implantable Electronic Device, Infective endocarditis, Generator pocket infection, Fever of unknown origin
Medical subject headings
Endocarditis, Fever of Unknown Origin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET CTOther

    Also called Positron emission tomography - computed tomography

    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.

Study groups in NCT02196753
Study groupRoleWhat they receive
CIED related infectionAll 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).
Receives: Other: PET CT
Non-infectiveControl 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
Receives: Other: PET CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 6 months

Secondary outcomes (4)

  1. Number of participants with remote infective complications

    Assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli)

    Measured: up to 6 months

  2. Number of participants with particular localizations of infection

    Incidence of particular localizations of infection

    Measured: up to 6 months

  3. Number of participants with sustained therapuetic decision

    Influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT (percentage)

    Measured: up to 6 months

  4. Number of participants with complications of PET CT

    Safety and complications of diagnostic process of CIED related infections with PET CT

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionSep 2016 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02196753
Sponsor's protocol ID
2.32/V/2014
Acronym
PET Guidance I
Status last verified
May 2015
First submitted
13 Jun 2014
Last updated
28 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Baddour LM, Epstein AE, Erickson CC, Knight BP, Levison ME, Lockhart PB, Masoudi FA, Okum EJ, Wilson WR, Beerman LB, Bolger AF, Estes NA 3rd, Gewitz M, Newburger JW, Schron EB, Taubert KA; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; Council on Cardiovascular Disease in Young; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Nursing; Council on Clinical Cardiology; Interdisciplinary Council on Quality of Care; American Heart Association. Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the American Heart Association. Circulation. 2010 Jan 26;121(3):458-77. doi: 10.1161/CIRCULATIONAHA.109.192665. Epub 2010 Jan 4.

    PubMed 20048212

  • Klug D, Balde M, Pavin D, Hidden-Lucet F, Clementy J, Sadoul N, Rey JL, Lande G, Lazarus A, Victor J, Barnay C, Grandbastien B, Kacet S; PEOPLE Study Group. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation. 2007 Sep 18;116(12):1349-55. doi: 10.1161/CIRCULATIONAHA.106.678664. Epub 2007 Aug 27.

    PubMed 17724263

  • Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.

    PubMed 21867833

  • Cabell CH, Heidenreich PA, Chu VH, Moore CM, Stryjewski ME, Corey GR, Fowler VG Jr. Increasing rates of cardiac device infections among Medicare beneficiaries: 1990-1999. Am Heart J. 2004 Apr;147(4):582-6. doi: 10.1016/j.ahj.2003.06.005.

    PubMed 15077071

  • Bongiorni MG, Marinskis G, Lip GY, Svendsen JH, Dobreanu D, Blomstrom-Lundqvist C; Scientific Initiative Committee, European Heart Rhythm Association. How European centres diagnose, treat, and prevent CIED infections: results of an European Heart Rhythm Association survey. Europace. 2012 Nov;14(11):1666-9. doi: 10.1093/europace/eus350.

    PubMed 23104858

  • Dababneh AS, Sohail MR. Cardiovascular implantable electronic device infection: a stepwise approach to diagnosis and management. Cleve Clin J Med. 2011 Aug;78(8):529-37. doi: 10.3949/ccjm.78a.10169.

    PubMed 21807925

  • Habib G, Hoen B, Tornos P, Thuny F, Prendergast B, Vilacosta I, Moreillon P, de Jesus Antunes M, Thilen U, Lekakis J, Lengyel M, Muller L, Naber CK, Nihoyannopoulos P, Moritz A, Zamorano JL; ESC Committee for Practice Guidelines. Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (new version 2009): the Task Force on the Prevention, Diagnosis, and Treatment of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the International Society of Chemotherapy (ISC) for Infection and Cancer. Eur Heart J. 2009 Oct;30(19):2369-413. doi: 10.1093/eurheartj/ehp285. Epub 2009 Aug 27. No abstract available.

    PubMed 19713420

  • Darouiche RO. Treatment of infections associated with surgical implants. N Engl J Med. 2004 Apr 1;350(14):1422-9. doi: 10.1056/NEJMra035415. No abstract available.

    PubMed 15070792

  • Ferguson TB Jr, Ferguson CL, Crites K, Crimmins-Reda P. The additional hospital costs generated in the management of complications of pacemaker and defibrillator implantations. J Thorac Cardiovasc Surg. 1996 Apr;111(4):742-51;discussion 751-2. doi: 10.1016/s0022-5223(96)70334-3.

    PubMed 8614134

  • Farkowski MM, Milkowski M, Dziuk M, Pytkowski M, Marciniak M, Kraska A, Szwed H, Sterlinski M. Economical aspect of PET/CT-guided diagnosis of suspected infective endocarditis in a patient with implantable cardioverter-defibrillator. Heart Lung. 2014 Jul-Aug;43(4):341-3. doi: 10.1016/j.hrtlng.2014.04.002. Epub 2014 May 22.

    PubMed 24856231

  • Sarrazin JF, Philippon F, Tessier M, Guimond J, Molin F, Champagne J, Nault I, Blier L, Nadeau M, Charbonneau L, Trottier M, O'Hara G. Usefulness of fluorine-18 positron emission tomography/computed tomography for identification of cardiovascular implantable electronic device infections. J Am Coll Cardiol. 2012 May 1;59(18):1616-25. doi: 10.1016/j.jacc.2011.11.059.

    PubMed 22538331

  • Ploux S, Riviere A, Amraoui S, Whinnett Z, Barandon L, Lafitte S, Ritter P, Papaioannou G, Clementy J, Jais P, Bordenave L, Haissaguerre M, Bordachar P. Positron emission tomography in patients with suspected pacing system infections may play a critical role in difficult cases. Heart Rhythm. 2011 Sep;8(9):1478-81. doi: 10.1016/j.hrthm.2011.03.062. Epub 2011 Apr 2.

    PubMed 21463705

  • Bensimhon L, Lavergne T, Hugonnet F, Mainardi JL, Latremouille C, Maunoury C, Lepillier A, Le Heuzey JY, Faraggi M. Whole body [(18) F]fluorodeoxyglucose positron emission tomography imaging for the diagnosis of pacemaker or implantable cardioverter defibrillator infection: a preliminary prospective study. Clin Microbiol Infect. 2011 Jun;17(6):836-44. doi: 10.1111/j.1469-0691.2010.03312.x. Epub 2010 Jul 15.

    PubMed 20636421

  • Cautela J, Alessandrini S, Cammilleri S, Giorgi R, Richet H, Casalta JP, Habib G, Raoult D, Mundler O, Deharo JC. Diagnostic yield of FDG positron-emission tomography/computed tomography in patients with CEID infection: a pilot study. Europace. 2013 Feb;15(2):252-7. doi: 10.1093/europace/eus335. Epub 2012 Nov 12.

    PubMed 23148119

  • Leccisotti L, Perna F, Lago M, Leo M, Stefanelli A, Calcagni ML, Pelargonio G, Narducci ML, Bencardino G, Bellocci F, Giordano A. Cardiovascular implantable electronic device infection: delayed vs standard FDG PET-CT imaging. J Nucl Cardiol. 2014 Jun;21(3):622-32. doi: 10.1007/s12350-014-9896-2. Epub 2014 Apr 10.

    PubMed 24715624

Questions about this trial

What is this clinical trial studying?

An observational study of Complications and Infective Endocarditis, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maciej Sterliński, MD, PhD (223434050 ext. +48, msterlinski@poczta.onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with established diagnosis (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02196753, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.

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