ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01916005
Recruitment Status : Unknown
Verified August 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 5, 2013
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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 or disease Intervention/treatment Phase
Prosthetic Valve Endocarditis (PVE) Device: 18F-FDG PET/CT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
Study Start Date : May 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: endocarditis Device: 18F-FDG PET/CT



Primary Outcome Measures :
  1. the diagnosis of prosthetic valve infective endocarditis [ Time Frame: 39months ]
    18F-fluorodeoxyglucose positron emission tomography


Secondary Outcome Measures :
  1. the reproducibility of the technique, [ Time Frame: 39 months ]
    the other diagnostic parameters of PET/CT (specificity and predictive values)

  2. the comparison of the sensitivity of PET/CT with that of echocardiography, [ Time Frame: 39 MONTHS ]
    the other diagnostic parameters of PET/CT (specificity and predictive values)

  3. the rate of detection of embolic events, [ Time Frame: 39 MONTHS ]
    the other diagnostic parameters of PET/CT (specificity and predictive values)

  4. the prognostic value of the technique (death/valve surgery) [ Time Frame: 39 MONTHS ]
    the other diagnostic parameters of PET/CT (specificity and predictive values)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01916005     History of Changes
Other Study ID Numbers: 2013-A00056-39
2013-01 ( Other Identifier: AP HM )
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Endocarditis
Heart Diseases
Cardiovascular Diseases
Fluorodeoxyglucose F18
Deoxyglucose
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents