Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Henri Mondor Hospital
RECRUITING
Créteil
Contact Information
Primary
Vania TACHER, PHD
vania.tacher@aphp.fr
01 49 81 29 29
Backup
Samia BALOUL
samia.baloul@aphp.fr
01 49 81 33 85
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2030-03-07
Participants
Target number of participants: 180
Treatments
Other: Prospective cohort of patients
Patients with suspected cardiac sarcoidosis
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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