Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a combined imaging technique called PET/MRI can help doctors better understand and diagnose cardiac sarcoidosis, a condition where clusters of inflammatory cells affect the heart. The researchers believe that using both PET and MRI together may provide important information about the disease’s progression and help identify which patients are at risk for serious heart complications, like sudden death. This could lead to more targeted treatments and better management of the condition.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with sarcoidosis, showing signs that the heart may be involved. This could include specific heart symptoms or abnormalities seen on cardiac tests. Participants can expect to undergo imaging tests that will help assess their condition. It’s important to note that some people may not be eligible due to factors like certain medical conditions, pregnancy, or having incompatible medical devices. If you’re interested, make sure to discuss it with your healthcare provider to see if this trial is a good fit for you.

Gender

ALL

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