Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01916005
First received: May 22, 2013
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified Duke criteria.

Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.

Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou European Hospital, Paris), the investigators plan to include consecutive patients suspected of having PVE. All of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of FDG uptake (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological modified Duke criteria determined during a 3-month follow-up (gold standard).


Condition Intervention
Prosthetic Valve Endocarditis (PVE)
Device: 18F-FDG PET/CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • the diagnosis of prosthetic valve infective endocarditis [ Time Frame: 39months ] [ Designated as safety issue: No ]
    18F-fluorodeoxyglucose positron emission tomography


Secondary Outcome Measures:
  • the reproducibility of the technique, [ Time Frame: 39 months ] [ Designated as safety issue: No ]
    the other diagnostic parameters of PET/CT (specificity and predictive values)

  • the comparison of the sensitivity of PET/CT with that of echocardiography, [ Time Frame: 39 MONTHS ] [ Designated as safety issue: No ]
    the other diagnostic parameters of PET/CT (specificity and predictive values)

  • the rate of detection of embolic events, [ Time Frame: 39 MONTHS ] [ Designated as safety issue: No ]
    the other diagnostic parameters of PET/CT (specificity and predictive values)

  • the prognostic value of the technique (death/valve surgery) [ Time Frame: 39 MONTHS ] [ Designated as safety issue: No ]
    the other diagnostic parameters of PET/CT (specificity and predictive values)


Estimated Enrollment: 174
Study Start Date: May 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: endocarditis Device: 18F-FDG PET/CT

  Eligibility

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

Inclusion Criteria:

  • unexplained persistent or recurrent fever >38°C;
  • and/or unexplained increased serum C-reactive protein (CRP) level >10 mg/L; and/or positive blood cultures, independent of the echocardiographic analysis results;
  • and/or positive serological testing for Coxiella burnetii, Bartonella spp., Mycoplasma pneumoniae, Legionella pneumophila, Aspergillus spp., or Tropheryma whipplei;
  • and/or a mass or a new partial prosthetic valve dehiscence observed using echocardiography.

Exclusion Criteria:

  • pregnancy,
  • an inability to lie flat,
  • a need for urgent cardiac surgery,
  • hemodynamic instability,
  • cardiac surgery <1 month ago,
  • and a blood glucose level >1.8 g/L. Patients with a poor PET/CT image quality
  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: NCT01916005

Contacts
Contact: FRANCK THUNY franck.thuny@aphm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: franck thuny       franck.thuny@ap-hm.fr   
Principal Investigator: franck THUNY         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01916005     History of Changes
Other Study ID Numbers: 2013-A00056-39, 2013-01
Study First Received: May 22, 2013
Last Updated: August 27, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Endocarditis
Heart Diseases
Cardiovascular Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014