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

NCT ID: NCT05954507

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2030-03-07

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.

Conditions

Cardiac Sarcoidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Prospective cohort of patients

Patients with suspected cardiac sarcoidosis

Group Type: OTHER

PET/MRI

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Positive pregnancy test result after inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu MAHEVAS, PHD

Role: STUDY_DIRECTOR

Assistance public Hôpitaux de Paris

Locations

Henri Mondor Hospital

Créteil, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Vania TACHER, PHD

Role: CONTACT

vania.tacher@aphp.fr

01 49 81 29 29

Samia BALOUL

Role: CONTACT

samia.baloul@aphp.fr

01 49 81 33 85

Other Identifiers

APHP191100

Identifier Type: -

Identifier Source: org_study_id