Cardiac SarcoidosisSARCASTIMNCT05954507
Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis
A study testing PET/MRI in people with Cardiac Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sarcoidosis
- What is being tested?
- PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2025to 7 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis
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
- Being tested
- PET/MRI
- Keywords
- Cardiac sarcoidosis, Combined PET/MRI, PET, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort of patients | Other | Patients with suspected cardiac sarcoidosis Receives: Diagnostic Test: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 months
Secondary outcomes (4)
Frequency of severe cardiological events between patients with and without Delayde MRI enhancement
Among patients with hypermetabolic FDG PET uptake
Measured: 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.
MRI- PET-; MRI- PET+; MRI+ PET-; and MRI+ PET+.
Measured: Up to month 24.
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).
Measured: Up to month 24.
Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.
For patients with initial pathological MRI-PET.
Measured: Up to month 3 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start7 Mar 2025
- Primary completion7 Mar 2030 (estimated)
- Study completion7 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu MAHEVAS, PHD, Study director, Assistance public Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954507
- Sponsor's protocol ID
- APHP191100
- Acronym
- SARCASTIM
- Status last verified
- Dec 2024
- First submitted
- 13 Jul 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT05954507
- Acronym / sponsor ID
- SARCASTIM / APHP191100
- Conditions
- Cardiac Sarcoidosis
- Keywords
- Cardiac sarcoidosis, Combined PET/MRI, PET, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 7 Mar 2030 (estimated)
- Study completion
- 7 Mar 2030 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort of patients | Other | Diagnostic Test: PET/MRIPatients with suspected cardiac sarcoidosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Sarcoidosis defined according to ATS/ERS/WASOG criteria
- Suspicion of cardiac involvement in sarcoidosis:
- Informed patient consent
- Membership of a social security scheme
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRIPET/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. | Diagnostic test | Prospective cohort of patients |
Primary outcome
Occurrence of a severe cardiological event
Time frame: 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
4 secondary outcomes
Frequency of severe cardiological events between patients with and without Delayde MRI enhancement
Time frame: 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.
Time frame: Up to month 24.
Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement
Time frame: Up to month 24.
Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.
Time frame: Up to month 3 and 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Related trials for Cardiac Sarcoidosis
RecruitingPhase 2
Repurposing Tilmanocept for Cardiac Sarcoidosis
Cardiac Sarcoidosis
RecruitingObservational study
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac Sarcoidosis
RecruitingObservational study
Prognostic Value of Clinical Cardiovascular MRI
Sarcoidosis
Recruiting
A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis
Cardiac Sarcoidosis, Infective Endocarditis
RecruitingObservational study
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthieu MAHEVAS, PHD study director
Assistance public Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI in people with Cardiac Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vania TACHER, PHD (01 49 81 29 29, vania.tacher@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a severe cardiological event (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.