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

NCT05954507 | Recruiting

• 1 other identifier: APHP191100
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiac sarcoidosis; Combined PET/MRI; PET; MRI

Outcome Measures

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

  Up to 24 months

Secondary Outcomes (4)

• Frequency of severe cardiological events between patients with and without Delayde MRI enhancement

  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.

  Up to month 24.

• Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement

  Up to month 24.

• Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.

  Up to month 3 and 12.

Study Arms (1)

Prospective cohort of patients

OTHER

Patients with suspected cardiac sarcoidosis

Diagnostic Test: PET/MRI

Interventions

PET/MRI 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.

Prospective cohort of patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Patients under AME

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, France

RECRUITING

Study Officials

• Matthieu MAHEVAS, PHD

  Assistance public Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Vania TACHER, PHD

CONTACT

01 49 81 29 29; vania.tacher@aphp.fr

Samia BALOUL

CONTACT

01 49 81 33 85; samia.baloul@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 20, 2023
• Study Start: March 7, 2025
• Primary Completion (Estimated): March 7, 2030
• Study Completion (Estimated): March 7, 2030
• Last Updated: April 2, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)