Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PET/MRI.
- Who it may be relevant to
- Registry conditions: Cardiac Sarcoidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis
Overview
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.
Interventions
- Diagnostic test PET/MRI
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.
Primary outcome measures
- Occurrence of a severe cardiological event [Time frame: Up to 24 months]
Secondary outcome measures (4)
- Frequency of severe cardiological events between patients with and without Delayde MRI enhancement [Time frame: 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. [Time frame: Up to month 24.]
- Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement [Time frame: Up to month 24.]
- Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment. [Time frame: Up to month 3 and 12.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Henri Mondor Hospital — Créteil
Identifiers
NCT: NCT05954507 · APHP191100