Clinical trial NCT05954507: Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis
Official title: Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Sarcoidosis
Keywords: Cardiac sarcoidosis
Combined PET/MRI
PET
MRI
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prognostic study of a prospective multicenter cohort of patients with suspected cardiac involvement in sarcoidosis.

All patients with suspected cardiac sarcoidosis meeting the inclusion criteria will be prospectively and consecutively included in each of the study centers. Patients will undergo cardiac PET/MRI within 15 days of inclusion, and will be followed up for 24 months.
Primary purpose: DIAGNOSTIC

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

Primary outcomes:
measure: Occurrence of a severe cardiological event
timeFrame: Up to 24 months
Secondary outcomes:
measure: Frequency of severe cardiological events between patients with and without Delayde MRI enhancement
timeFrame: Up to 24 months.
measure: Frequency of severe cardiological events according to each modality of PET/MRI results in terms of Delayde MRI enhancement and hypermetabolic fixation on PET.
timeFrame: Up to month 24.
measure: Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement
timeFrame: Up to month 24.
measure: Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.
timeFrame: Up to month 3 and 12.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance public Hôpitaux de Paris
name: Matthieu MAHEVAS, PHD
role: STUDY_DIRECTOR
References: