Infective EndocarditisCARTEPNCT07029295
Evaluation of the Impact of a Patient Education Protocol on the Quality of 18F-FDG PET Imaging Indicated for Investigation of Cardiac Inflammation
A study testing Sending a link to the video, Compliance questionnaire and Determination of beta-hydroxybutyrate (BHB) in capillary blood in people with Infective Endocarditis and Cardiac Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The aim of this study is to assess the impact of implementing a patient education and preparation protocol for FDG PET (18F-FDG PET) imaging on the quality of imaging results. 18F-FDG (18Fluor-FluoroDesoxyGlucose) PET (Positron Emission Tomography) is indicated for the diagnosis of cardiac inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis, Cardiac Sarcoidosis
- What is being tested?
- Sending a link to the video, Compliance questionnaire and Determination of beta-hydroxybutyrate (BHB) in capillary blood
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jul 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Presence of a prescription validated by the nuclear medicine department for an 18F-FDG PET scan for the detection of inflammation of cardiac inflammation or infection
- Age greater than or equal to 18
- Membership of a social security scheme or equivalent
- Patients with an e-mail address
- Patients who understand French
- Collection of patient consent
Who cannot join
- Pregnancy or breast-feeding
- Patients (inpatients or outpatients) already on a diet (including ketogenic)
- Patients who do not understand protocol
- Patients deprived of liberty by judicial or administrative decision
- Patients under legal protection (guardianship/trusteeship)
- Patients under court protection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hôpital Cochin - AP-HP, Service de médecine nucléaire
Paris
Olivier CASASSUS-BUILHE, +33158412323, olivier.casassus-builhe@aphp.fr
Olivier CASASSUS-BUILHE
Hôpital Européen Georges Pompidou - AP-HP, Service de médecine nucléaire
Paris
Julien HO, +33156093981, julien.ho@aphp.fr
Julien HO
About this study
The aim of this study is to assess the impact of implementing a patient education and preparation protocol for FDG PET (18F-FDG PET) imaging on the quality of imaging results.
18F-FDG (18Fluor-FluoroDesoxyGlucose) PET (Positron Emission Tomography) is indicated for the diagnosis of cardiac inflammation. To detect cardiac inflammation, the myocardium (heart muscle) must be prevented from absorbing glucose from the diet (FDG). To achieve this, patient preparation is essential. Poor preparation can compromise the interpretation of results, causing diagnostic delay.
To answer the research question, the investigators plan to include 138 people with suspected infective endocarditis or cardiac sarcoidosis, in two institutions of the Assistance Publique - Hôpitaux de Paris: Hôpital Européen Georges Pompidou and Hôpital Cochin-Port-Royal, located respectively at 20 rue Leblanc 75015 Paris and 27 rue du Faubourg Saint-Jacques 75014 Paris.
Read the detailed description
18F-FDG (18Fluor-FluoroDesoxyGlucose) PET (Positron Emission Tomography) is indicated for the diagnosis of infective endocarditis or cardiac sarcoidosis. Detection of cardiac inflammation requires suppression of physiological glucose (FDG) uptake in the myocardium. To achieve this, patient preparation (ketogenic diet and fasting) is essential. Failure rates vary from center to center. Poor preparation can compromise interpretation, causing diagnostic delay, additional exposure to ionizing radiation and cost. Interpretation of the examination requires suppressing FDG uptake in the myocardium in order to identify FDG uptake in activated inflammatory cells. With this study, the investigators hope to demonstrate that an intervention upstream of the examination will increase the success rate of the 18F-FDG PET examination indicated for cardiac sarcoidosis or infective endocarditis. This will make it possible to avoid reprogramming the examination in the event of failure, and thus limit the patient's additional exposure to ionizing radiation (radiation protection), and avoid a loss of chance for the patient as well as additional costs for health insurance.
Main objective: To evaluate the benefit of implementing a patient education protocol prior to myocardial 18F-FDG PET on the removal of residual myocardial fixation compared with the usual procedure of sending instructions.
Primary endpoint: Success rate of suppression of residual myocardial FDG uptake. Success criteria according to 4 grades. Grade 1 (no residual FDG fixation), grade 2 (moderate FDG fixation in basal LV segments), grade 3 (residual FDG fixation interfering with interpretation) or grade 4 (diffuse and intense FDG fixation). Grades 1 and 2 define success.
Secondary objectives: By comparing the control group (usual procedure) with the intervention group (new procedure):
A - Evaluate the value of determining ketone bodies in capillary blood before the 18F-FDG PET examination indicated for infectious endocarditis or cardiac sarcoidosis, to predict its success.
B - Evaluate whether the patient education protocol leads to greater compliance with dietary instructions prior to the 18F-FDG PET scan.
C - Investigate whether certain drug excipients are likely to influence the results of the 18F-FDG PET scan, by retrieving the list of drugs taken by the patient 24 hours prior to the scan. Indeed, some excipients may contain fast sugars and this could, perhaps, independently of compliance with dietary instructions, lead to failure of the 18F-FDG PET scan.
Secondary endpoints:
A - Measurement of ketone bodies (BHB) on a capillary blood sample taken just before the examination.
B - Use of a questionnaire (cf. appendix 2) drawn up and distributed by the radio handlers to the patient on arrival in the department on the day of the examination.
C - Collection of medications taken by the patient in the 24 hours preceding the examination.
- Conditions
- Infective Endocarditis, Cardiac Sarcoidosis
- Being tested
- Sending a link to the video, Compliance questionnaire, Determination of beta-hydroxybutyrate (BHB) in capillary blood
- Keywords
- 18F-FDG, PET, infective endocarditis, cardiac sarcoidosis, patient preparation, patient education protocol
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sending a link to the videoOther
Sending a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow.
Compliance questionnaireBehavioural
Patient completes a questionnaire on compliance with preparation instructions on the day of the imaging test.
Determination of beta-hydroxybutyrate (BHB) in capillary bloodBiological
Determination of beta-hydroxybutyrate (BHB) in capillary blood prior to imaging examination.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | standard procedure (transmission of an instructions sent by e-mail) + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood before imaging. Receives: Behavioral: Compliance questionnaire; Biological: Determination of beta-hydroxybutyrate (BHB) in capillary blood |
| Intervention group | Experimental | standard procedure accompanied by a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood prior to imaging. Receives: Other: Sending a link to the video; Behavioral: Compliance questionnaire; Biological: Determination of beta-hydroxybutyrate (BHB) in capillary blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the benefit of implementing a patient education protocol prior to myocardial 18F-FDG PET on the removal of residual myocardial fixation compared to the usual procedure of sending instructions.
Interpretation of imaging results :
Success rate of suppression of residual myocardial FDG uptake. Success criteria according to 4 grades. Grade 1 (no residual FDG uptake), grade 2 (moderate FDG uptake in basal LV segments), grade 3 (residual FDG fixation interfering with interpretation) or grade 4 (diffuse, intense FDG uptake). Grades 1 and 2 define success.
Centralized review by two independent nuclear medicine physicians and definition of residual FDG uptake in the myocardium blinded to the inclusion group. If there was a discrepancy between the scores, rereading by a 3rd nuclear physician.
Measured: After the imaging (approximately 1 month after the appointment is scheduled for the imaging)
Secondary outcomes (3)
Evaluate the value of determining ketone bodies in capillary blood prior to the 18F-FDG PET indicated for infectious endocarditis or cardiac sarcoidosis to predict its success
Measurement of ketone bodies (BHB) on a capillary blood sample just before the imaging.
Measured: Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)
Evaluate whether the patient education protocol leads to greater compliance with dietary instructions prior to 18F-FDG PET.
Use of a questionnaire prepared and distributed by radio operators to the patient on arrival on the day of the imaging.
Measured: Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)
Investigate whether certain drug excipients are likely to influence PET-18F-FDG results
Collection of medications taken by the patient in the 24 hours preceding the imaging.
Measured: Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial in two parallel groups: * Control group: standard procedure (transmission of instructions sent by e-mail) + compliance questionnaire to be completed on arrival in the day of imaging + BHB (Beta-hydroxybutyrate) assay on capillary blood before imaging. * Intervention group: standard procedure accompanied by a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood prior to imaging.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien HO, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029295
- Sponsor's protocol ID
- APHP250343
- Other IDs
- 2025-A00410-49, 25.00839.000457
- Acronym
- CARTEP
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Patient Education Protocol on the Quality of 18F-FDG PET Imaging Indicated for Investigation of Cardiac Inflammation
- ClinicalTrials.gov ID
- NCT07029295
- Acronym / sponsor ID
- CARTEP / APHP250343
- Conditions
- Infective Endocarditis, Cardiac Sarcoidosis
- Keywords
- 18F-FDG, PET, infective endocarditis, cardiac sarcoidosis, patient preparation, patient education protocol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- 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 aim of this study is to assess the impact of implementing a patient education and preparation protocol for FDG PET (18F-FDG PET) imaging on the quality of imaging results.
18F-FDG (18Fluor-FluoroDesoxyGlucose) PET (Positron Emission Tomography) is indicated for the diagnosis of cardiac inflammation. To detect cardiac inflammation, the myocardium (heart muscle) must be prevented from absorbing glucose from the diet (FDG). To achieve this, patient preparation is essential. Poor preparation can compromise the interpretation of results, causing diagnostic delay.
To answer the research question, the investigators plan to include 138 people with suspected infective endocarditis or cardiac sarcoidosis, in two institutions of the Assistance Publique - Hôpitaux de Paris: Hôpital Européen Georges Pompidou and Hôpital Cochin-Port-Royal, located respectively at 20 rue Leblanc 75015 Paris and 27 rue du Faubourg Saint-Jacques 75014 Paris.
Detailed description
18F-FDG (18Fluor-FluoroDesoxyGlucose) PET (Positron Emission Tomography) is indicated for the diagnosis of infective endocarditis or cardiac sarcoidosis. Detection of cardiac inflammation requires suppression of physiological glucose (FDG) uptake in the myocardium. To achieve this, patient preparation (ketogenic diet and fasting) is essential. Failure rates vary from center to center. Poor preparation can compromise interpretation, causing diagnostic delay, additional exposure to ionizing radiation and cost. Interpretation of the examination requires suppressing FDG uptake in the myocardium in order to identify FDG uptake in activated inflammatory cells. With this study, the investigators hope to demonstrate that an intervention upstream of the examination will increase the success rate of the 18F-FDG PET examination indicated for cardiac sarcoidosis or infective endocarditis. This will make it possible to avoid reprogramming the examination in the event of failure, and thus limit the patient's additional exposure to ionizing radiation (radiation protection), and avoid a loss of chance for the patient as well as additional costs for health insurance.
Main objective: To evaluate the benefit of implementing a patient education protocol prior to myocardial 18F-FDG PET on the removal of residual myocardial fixation compared with the usual procedure of sending instructions.
Primary endpoint: Success rate of suppression of residual myocardial FDG uptake. Success criteria according to 4 grades. Grade 1 (no residual FDG fixation), grade 2 (moderate FDG fixation in basal LV segments), grade 3 (residual FDG fixation interfering with interpretation) or grade 4 (diffuse and intense FDG fixation). Grades 1 and 2 define success.
Secondary objectives: By comparing the control group (usual procedure) with the intervention group (new procedure):
A - Evaluate the value of determining ketone bodies in capillary blood before the 18F-FDG PET examination indicated for infectious endocarditis or cardiac sarcoidosis, to predict its success.
B - Evaluate whether the patient education protocol leads to greater compliance with dietary instructions prior to the 18F-FDG PET scan.
C - Investigate whether certain drug excipients are likely to influence the results of the 18F-FDG PET scan, by retrieving the list of drugs taken by the patient 24 hours prior to the scan. Indeed, some excipients may contain fast sugars and this could, perhaps, independently of compliance with dietary instructions, lead to failure of the 18F-FDG PET scan.
Secondary endpoints:
A - Measurement of ketone bodies (BHB) on a capillary blood sample taken just before the examination.
B - Use of a questionnaire (cf. appendix 2) drawn up and distributed by the radio handlers to the patient on arrival in the department on the day of the examination.
C - Collection of medications taken by the patient in the 24 hours preceding the examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial in two parallel groups: * Control group: standard procedure (transmission of instructions sent by e-mail) + compliance questionnaire to be completed on arrival in the day of imaging + BHB (Beta-hydroxybutyrate) assay on capillary blood before imaging. * Intervention group: standard procedure accompanied by a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood prior to imaging.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Compliance questionnaire, Biological: Determination of beta-hydroxybutyrate (BHB) in capillary bloodstandard procedure (transmission of an instructions sent by e-mail) + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood before imaging. |
| Intervention group | Experimental | Other: Sending a link to the video, Behavioral: Compliance questionnaire, Biological: Determination of beta-hydroxybutyrate (BHB) in capillary bloodstandard procedure accompanied by a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood prior to imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of a prescription validated by the nuclear medicine department for an 18F-FDG PET scan for the detection of inflammation of cardiac inflammation or infection
- Age greater than or equal to 18
- Membership of a social security scheme or equivalent
- Patients with an e-mail address
- Patients who understand French
Key exclusion criteria (6 listed)
- Pregnancy or breast-feeding
- Patients (inpatients or outpatients) already on a diet (including ketogenic)
- Patients who do not understand protocol
- Patients deprived of liberty by judicial or administrative decision
- Patients under legal protection (guardianship/trusteeship)
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 |
|---|---|---|
| Sending a link to the videoSending a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow. | Other | Intervention group |
| Compliance questionnairePatient completes a questionnaire on compliance with preparation instructions on the day of the imaging test. | Behavioural | Control group, Intervention group |
| Determination of beta-hydroxybutyrate (BHB) in capillary bloodDetermination of beta-hydroxybutyrate (BHB) in capillary blood prior to imaging examination. | Biological | Control group, Intervention group |
Primary outcome
Evaluate the benefit of implementing a patient education protocol prior to myocardial 18F-FDG PET on the removal of residual myocardial fixation compared to the usual procedure of sending instructions.
Time frame: After the imaging (approximately 1 month after the appointment is scheduled for the imaging)
Interpretation of imaging results : Success rate of suppression of residual myocardial FDG uptake. Success criteria according to 4 grades. Grade 1 (no residual FDG uptake), grade 2 (moderate FDG uptake in basal LV segments), grade 3 (residual FDG fixation interfering with interpretation) or grade 4 (diffuse, intense FDG uptake). Grades 1 and 2 define success. Centralized review by two independent nuclear medicine physicians and definition of residual FDG uptake in the myocardium blinded to the inclusion group. If there was a discrepancy between the scores, rereading by a 3rd nuclear physician.
3 secondary outcomes
Evaluate the value of determining ketone bodies in capillary blood prior to the 18F-FDG PET indicated for infectious endocarditis or cardiac sarcoidosis to predict its success
Time frame: Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)
Evaluate whether the patient education protocol leads to greater compliance with dietary instructions prior to 18F-FDG PET.
Time frame: Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)
Investigate whether certain drug excipients are likely to influence PET-18F-FDG results
Time frame: Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Julien HO principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sending a link to the video, Compliance questionnaire and Determination of beta-hydroxybutyrate (BHB) in capillary blood in people with Infective Endocarditis and Cardiac Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 6 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: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youcef SEKOUR (+33156095823, youcef.sekour@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the benefit of implementing a patient education protocol prior to myocardial 18F-FDG PET on the removal of residual myocardial fixation compared to the usual procedure of sending instructions. (time frame: After the imaging (approximately 1 month after the appointment is scheduled for the imaging)). 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 19 Jun 2025.