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

Cardiac Sarcoidosis Clinical Trial

— SARCASTIM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05954507
• Other study ID #: APHP191100
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2029

Study information

• Verified date: July 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Vania TACHER, PHD
• Phone: 01 49 81 29 29
• Email: vania.tacher[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 1, 2029
• Est. primary completion date: May 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Sarcoidosis
• Sarcoidosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of severe cardiological events between patients with and without Delayde MRI enhancement	Among patients with hypermetabolic FDG PET uptake	Up to 24 months.
Secondary	Frequency of severe cardiological events according to each modality of PET/MRI results in terms of Delayde MRI enhancement and hypermetabolic fixation on PET.	MRI- PET-; MRI- PET+; MRI+ PET-; and MRI+ PET+.	Up to month 24.
Secondary	Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement	Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement (absent, possible, probable or very probable) by each examination (MRI alone, PET alone, or PET/MRI) in relation to the diagnosis established at two years (reference).	Up to month 24.
Secondary	Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.	For patients with initial pathological MRI-PET.	Up to month 3 and 12.