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Cardiac damage is the second leading cause of death in patients with sarcoidosis, after lung damage. Today's challenge is to diagnose the disease as effectively as possible, and to develop tools for better risk stratification, especially for sudden death, in order to better target therapies and implantable devices, such as corticoids and immunosuppressant.
The hypothesis is that combined PET (Positron Emission Tomography)/MRI (Magnetic Resonance Imaging) could be a relevant prognostic marker of progression, and would significantly improve diagnostic performance in patients with suspected cardiac sarcoidosis (CS). This study will also make it possible to distinguish sequellar fibrosis lesions from granulomatous lesions and assess the therapeutic response. Incorporating PET/MRI into the diagnostic strategy for patients with suspected CS could therefore improve their management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort of patients | Other | Patients with suspected cardiac sarcoidosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MRI | Diagnostic Test | PET/MRI is a new-generation hybrid camera capable of simultaneously performing FDG positron emission tomography and gadolinium-injected MRI. PET/MRI could be a relevant prognostic marker of progression, and could significantly improve diagnostic performance in patients with suspected cardiac sarcoidosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a severe cardiological event | Occurrence during follow-up of at least one of the severe cardiological events listed below attributed to sarcoidosis, assessed at 24 months:
| Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of severe cardiological events between patients with and without Delayde MRI enhancement | Among patients with hypermetabolic FDG PET uptake | Up to 24 months. |
| Frequency of severe cardiological events according to each modality of PET/MRI results in terms of Delayde MRI enhancement and hypermetabolic fixation on PET. |
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Inclusion Criteria:
Age ≥ 18 years
Sarcoidosis defined according to ATS/ERS/WASOG criteria
Suspicion of cardiac involvement in sarcoidosis:
Informed patient consent
Membership of a social security scheme
Exclusion Criteria:
Exclusion criteria (post signature of consent) for women of reproductive age :
- Positive pregnancy test result after inclusion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vania TACHER, PHD | Contact | 01 49 81 29 29 | vania.tacher@aphp.fr | |
| Samia BALOUL | Contact | 01 49 81 33 85 | samia.baloul@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Matthieu MAHEVAS, PHD | Assistance public Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Recruiting | Créteil | France |
DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Prognostic study of a prospective multicenter cohort of patients with suspected cardiac involvement in sarcoidosis.
All patients with suspected cardiac sarcoidosis meeting the inclusion criteria will be prospectively and consecutively included in each of the study centers. Patients will undergo cardiac PET/MRI within 15 days of inclusion, and will be followed up for 24 months.
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|
MRI- PET-; MRI- PET+; MRI+ PET-; and MRI+ PET+. |
| Up to month 24. |
| Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement | Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement (absent, possible, probable or very probable) by each examination (MRI alone, PET alone, or PET/MRI) in relation to the diagnosis established at two years (reference). | Up to month 24. |
| Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment. | For patients with initial pathological MRI-PET. | Up to month 3 and 12. |