search
Back to results

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

Primary Purpose

Cardiac Sarcoidosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/MRI
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Sarcoidosis focused on measuring Cardiac sarcoidosis, Combined PET/MRI, PET, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Prospective cohort of patients

    Arm Description

    Patients with suspected cardiac sarcoidosis

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Frequency of severe cardiological events between patients with and without Delayde MRI enhancement
    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.
    MRI- PET-; MRI- PET+; MRI+ PET-; and MRI+ PET+.
    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).
    Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.
    For patients with initial pathological MRI-PET.

    Full Information

    First Posted
    July 13, 2023
    Last Updated
    July 26, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05954507
    Brief Title
    Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis
    Acronym
    SARCASTIM
    Official Title
    Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2028 (Anticipated)
    Study Completion Date
    December 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Sarcoidosis
    Keywords
    Cardiac sarcoidosis, Combined PET/MRI, PET, MRI

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prospective cohort of patients
    Arm Type
    Other
    Arm Description
    Patients with suspected cardiac sarcoidosis
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    PET/MRI
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Occurrence of a severe cardiological event
    Description
    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
    Time Frame
    Up to 24 months
    Secondary Outcome Measure Information:
    Title
    Frequency of severe cardiological events between patients with and without Delayde MRI enhancement
    Description
    Among patients with hypermetabolic FDG PET uptake
    Time Frame
    Up to 24 months.
    Title
    Frequency of severe cardiological events according to each modality of PET/MRI results in terms of Delayde MRI enhancement and hypermetabolic fixation on PET.
    Description
    MRI- PET-; MRI- PET+; MRI+ PET-; and MRI+ PET+.
    Time Frame
    Up to month 24.
    Title
    Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement
    Description
    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).
    Time Frame
    Up to month 24.
    Title
    Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.
    Description
    For patients with initial pathological MRI-PET.
    Time Frame
    Up to month 3 and 12.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vania TACHER, PHD
    Phone
    01 49 81 29 29
    Email
    vania.tacher@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samia BALOUL
    Phone
    01 49 81 33 85
    Email
    samia.baloul@aphp.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthieu MAHEVAS, PHD
    Organizational Affiliation
    Assistance public Hôpitaux de Paris
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs