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The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.
Introduction:
Infective endocarditis (IE) is a rare disease, often difficult to diagnose with a high mortality rate. Extra-cardiac manifestations, which can occur in 30 to 80% of cases, impact the outcome of the disease. Identifying these manifestations may help confirm an uncertain diagnosis and optimize patients' management.
18-FDG PET/CT imaging, widely used for cancer staging, may also detect hyper-metabolic areas related to extracardiac infectious complications of IE. It provides the opportunity to detect all extracardiac IE infectious complications through a single examination. The impact of 18-FDG PET/CT imaging on the management of IE has yet to be completely evaluated.
Hypothesis:
18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization.
Primary objective:
To evaluate the impact of 18-FDG PET/CT on patients' management, as measured by changes in IE therapeutic plans.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18-FDG PET/CT scan | Experimental | All patients will undergo a whole body PET/CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18-FDG PET/CT scan | Procedure | Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a change in IE therapeutic plan | at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication…) or any modification of surgery (type, timing, indications…) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Duke-Li classification modifications | Proportion of patients with change in diagnostic classification of IE (definite, possible, excluded) according to the Duke-Li classification | 6 months |
| Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Duval, Professor | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bichat Claude Bernard Hospital | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32828775 | Result | Boursier C, Duval X, Bourdon A, Imbert L, Mahida B, Chevalier E, Claudin M, Hoen B, Goehringer F, Selton-Suty C, Roch V, Lamiral Z, Humbert O, Rouzet F, Marie PY; AEPEI-TEPvENDO study group. ECG-Gated Cardiac FDG PET Acquisitions Significantly Improve Detectability of Infective Endocarditis. JACC Cardiovasc Imaging. 2020 Dec;13(12):2691-2693. doi: 10.1016/j.jcmg.2020.06.036. Epub 2020 Aug 19. No abstract available. | |
| 32488236 |
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| ID | Term |
|---|---|
| D004696 | Endocarditis |
| D014095 | Tooth, Impacted |
| D004194 | Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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1/ in detecting valve damages and extracardiac complications and 2/ in identify the portal of entry of IE |
| 6 months |
| 6-month mortality rate | number of dead patients 6 months after inclusion | 6 months |
| Determinants of change in therapeutic plan as defined in primary outcome | Clinical and biological determinants of therapeutic changes | 6 months |
| 18-FDG PET/CT inter-reader reproducibility | questionnaire | 6 months |
| Result |
| Duval X, Le Moing V, Tubiana S, Esposito-Farese M, Ilic-Habensus E, Leclercq F, Bourdon A, Goehringer F, Selton-Suty C, Chevalier E, Boutoille D, Piriou N, Le Tourneau T, Chirouze C, Seronde MF, Morel O, Piroth L, Eicher JC, Humbert O, Revest M, Thebault E, Devillers A, Delahaye F, Boibieux A, Gregoire B, Hoen B, Laouenan C, Iung B, Rouzet F; AEPEI-TEPvENDO study group. Impact of Systematic Whole-body 18F-Fluorodeoxyglucose PET/CT on the Management of Patients Suspected of Infective Endocarditis: The Prospective Multicenter TEPvENDO Study. Clin Infect Dis. 2021 Aug 2;73(3):393-403. doi: 10.1093/cid/ciaa666. |
| 32043240 | Result | Boursier C, Duval X, Mahida B, Hoen B, Goehringer F, Selton-Suty C, Chevalier E, Roch V, Lamiral Z, Bourdon A, Piriou N, Pallardy A, Morel O, Rouzet F, Marie PY; AEPEI-TEPvENDO Study Group. Hypermetabolism of the spleen or bone marrow is an additional albeit indirect sign of infective endocarditis at FDG-PET. J Nucl Cardiol. 2021 Dec;28(6):2533-2542. doi: 10.1007/s12350-020-02050-2. Epub 2020 Feb 10. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |