Informations générales (source: ClinicalTrials.gov)
Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2025
mars 2030
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | TACHER Vania | 27/12/2025 07:29:45 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 27/12/2025 07:29:46 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Tenon | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Henri Mondor Hospital - Créteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 years
- Sarcoidosis defined according to ATS/ERS/WASOG criteria
- Suspicion of cardiac involvement in sarcoidosis:
- Clinical manifestations (syncope, lipothymia, persistent palpitations, signs of
heart failure) and/or
- Cardiac rhythm or conduction disorder (Mobitz type 2 atrioventricular block
(AVB), AVB 3, right or left bundle branch block, Q wave in at least 2 leads,
ventricular arrhythmia (ventricular mono/polymorphic complexes> 1000 per 24 h,
ventricular tachycardia, ventricular fibrillation), unexplained sustained VT or
epsilon wave) and/or
- Compatible cardiac ultrasound abnormality: left ventricular dilatation, septal
thickening or wall thinning (especially basal), segmental kinetic disorder and
wall aneurysm without coronary anomaly, altered left ventricular ejection
fraction, altered diastolic function, altered right ventricular systolic
function.
- Informed patient consent
- Membership of a social security scheme
- Age ≥ 18 years
- Sarcoidosis defined according to ATS/ERS/WASOG criteria
- Suspicion of cardiac involvement in sarcoidosis:
- Clinical manifestations (syncope, lipothymia, persistent palpitations, signs of
heart failure) and/or
- Cardiac rhythm or conduction disorder (Mobitz type 2 atrioventricular block
(AVB), AVB 3, right or left bundle branch block, Q wave in at least 2 leads,
ventricular arrhythmia (ventricular mono/polymorphic complexes> 1000 per 24 h,
ventricular tachycardia, ventricular fibrillation), unexplained sustained VT or
epsilon wave) and/or
- Compatible cardiac ultrasound abnormality: left ventricular dilatation, septal
thickening or wall thinning (especially basal), segmental kinetic disorder and
wall aneurysm without coronary anomaly, altered left ventricular ejection
fraction, altered diastolic function, altered right ventricular systolic
function.
- Informed patient consent
- Membership of a social security scheme
- Psychiatric illness not controlled by treatment
- Claustrophobia
- Known pregnancy or breast-feeding patient
- Unbalanced diabetes (influence on carbohydrate metabolism for PET)
- Previous infarction or known coronary disease
- Known allergy to gadolinium and fluoro-desoxyglucose and their excipients
- Renal insufficiency (Clairance < 30 mL/min/1.73m2)
- Implanted pacemaker not compatible with a 3 Teslas magnetic field
- Patients with ocular metallic foreign bodies, pacemakers, neurostimulators, cochlear
implants, metallic heart valves, vascular clips formerly implanted on cranial
aneurysms and, in general, any non-removably implanted electronic medical equipment
- Inability or refusal to follow a low-carbohydrate diet for 24 hours, followed by a
6-hour fast required prior to the examination
- Patient unable to hold a 10-second apnea.
- Patient deprived of liberty by judicial or administrative decision
- Patient under legal protection (guardianship, curatorship)
- Participation in other interventional research involving the human person or being
in the exclusion period following previous research involving the human person
- Patients under AME
Exclusion criteria (post signature of consent) for women of reproductive age :
- Positive pregnancy test result after inclusion