NCT05954507 Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis
| NCT ID | NCT05954507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Cardiac Sarcoidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-03-07 |
| Primary Completion | 2030-03-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-03-07 with a primary completion date of 2030-03-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 Exclusion Criteria: * 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
Contact & Investigator
Matthieu MAHEVAS, PHD
STUDY DIRECTOR
Assistance public Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05954507 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Sarcoidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05954507 currently recruiting?
Yes, NCT05954507 is actively recruiting participants. Contact the research team at vania.tacher@aphp.fr for enrollment information.
Where is the NCT05954507 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT05954507 clinical trial?
NCT05954507 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Matthieu MAHEVAS, PHD at Assistance public Hôpitaux de Paris. The trial plans to enroll 180 participants.