Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis
ConditionCardiac Sarcoidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Sarcoidosis defined according to ATS/ERS/WASOG criteria
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
Disqualifiers
Psychiatric illness not controlled by treatment
Claustrophobia
Known pregnancy or breast-feeding patient
Unbalanced diabetes (influence on carbohydrate metabolism for PET)
Trial design
Design model
Single group
Treatments tested in this trial
PET/MRI
Diagnostic testPET/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.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Prospective cohort of patientsOther 1 intervention
Trial outcomes
Primary outcomes
1
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: * Death from cardiac causes. * Placement of an automatic implantable defibrillator or pacemaker. * Conduction disorder (Mobitz type 2 atrioventricular block (AVB), AVB 3, ventricular arrhythmia (ventricular mono/polymorphic complexes \> 1000 per 24 h, ventricular tachycardia (VT), ventricular fibrillation), unexplained sustained VT). * Degradation of cardiac function of more than 10% of LVEF assessed by transthoracic (TTE) or cardiac MRI. * Acute heart failure with no other known cause
Time frame
Up to 24 monthsSecondary outcomes
1
Frequency of severe cardiological events between patients with and without Delayde MRI enhancement
Among patients with hypermetabolic FDG PET uptake
Time frame
Up to 24 months.2
Frequency of severe cardiological events according to each modality of PET/MRI results in terms of Delayde MRI enhancement and hypermetabolic fixation on PET.
MRI- PET-; MRI- PET+; MRI+ PET-; and MRI+ PET+.
Time frame
Up to month 24.3
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).
Time frame
Up to month 24.4
Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.
For patients with initial pathological MRI-PET.
Time frame
Up to month 3 and 12.Sponsors and contacts
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Source ClinicalTrials.gov