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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954507

Collaborator

(none)

180

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Cardiac damage is the main cause of death in patients with sarcoidosis, after pulmonary 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Sarcoidosis	Diagnostic Test: PET/MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Other: Prospective cohort of patients Patients with suspected cardiac sarcoidosis	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.

Arm

Intervention/Treatment

Other: Prospective cohort of patients

Patients with suspected cardiac sarcoidosis

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.

Outcome Measures

Primary Outcome Measures

Occurrence of a severe cardiological event [Up to 24 months]
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

Secondary Outcome Measures

Frequency of severe cardiological events between patients with and without Delayde MRI enhancement [Up to 24 months.]
Among patients with hypermetabolic FDG PET uptake
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.]
MRI- PET-; MRI- PET+; MRI+ PET-; and MRI+ PET+.
Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement [Up to month 24.]
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).
Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment. [Up to month 3 and 12.]
For patients with initial pathological MRI-PET.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Pregnant 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 12-hour fast required prior to the examination.
Patient unable to hold a 10-second apnea.
Patient deprived of liberty by judicial or administrative decision

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Study Director: Matthieu MAHEVAS, PHD, Assistance public Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT05954507

Other Study ID Numbers:

APHP191100

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 28, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Additional relevant MeSH terms:

Sarcoidosis

Study Results

No Results Posted as of Jul 28, 2023