Prosthetic Valve Endocarditis (PVE)NCT01916005
Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
A study testing 18F-FDG PET/CT in people with Prosthetic Valve Endocarditis (PVE), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Valve Endocarditis (PVE)
- What is being tested?
- 18F-FDG PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2014to 21 Apr 2023
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Prosthetic Valve Endocarditis (PVE)
- Being tested
- 18F-FDG PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTDevice
| Study group | Role | What they receive |
|---|---|---|
| endocarditis | Experimental | Not described Receives: Device: 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnosis of prosthetic valve infective endocarditis
18F-fluorodeoxyglucose positron emission tomography
Measured: 39months
Secondary outcomes (4)
the reproducibility of the technique,
the other diagnostic parameters of PET/CT (specificity and predictive values)
Measured: 39 months
the comparison of the sensitivity of PET/CT with that of echocardiography,
the other diagnostic parameters of PET/CT (specificity and predictive values)
Measured: 39 MONTHS
the rate of detection of embolic events,
the other diagnostic parameters of PET/CT (specificity and predictive values)
Measured: 39 MONTHS
the prognostic value of the technique (death/valve surgery)
the other diagnostic parameters of PET/CT (specificity and predictive values)
Measured: 39 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start5 Feb 2014
- Primary completion20 Mar 2018
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Valve Endocarditis (PVE)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916005
- Sponsor's protocol ID
- 2013-A00056-39
- Other IDs
- 2013-01
- Status last verified
- Apr 2023
- First submitted
- 22 May 2013
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
- ClinicalTrials.gov ID
- NCT01916005
- Acronym / sponsor ID
- 2013-A00056-39
- Conditions
- Prosthetic Valve Endocarditis (PVE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endocarditis | Experimental | Device: 18F-FDG PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- pregnancy,
- an inability to lie flat,
- a need for urgent cardiac surgery,
- hemodynamic instability,
- cardiac surgery <1 month ago,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CT | Device | endocarditis |
Primary outcome
the diagnosis of prosthetic valve infective endocarditis
Time frame: 39months
18F-fluorodeoxyglucose positron emission tomography
4 secondary outcomes
the reproducibility of the technique,
Time frame: 39 months
the comparison of the sensitivity of PET/CT with that of echocardiography,
Time frame: 39 MONTHS
the rate of detection of embolic events,
Time frame: 39 MONTHS
the prognostic value of the technique (death/valve surgery)
Time frame: 39 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET/CT in people with Prosthetic Valve Endocarditis (PVE), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 24 Apr 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnosis of prosthetic valve infective endocarditis (time frame: 39months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2023.