Evaluating PET/MRI for cardiac sarcoidosis prognosis
Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis
This study is testing if using a special imaging technique called PET/MRI can help doctors better understand and treat people with cardiac sarcoidosis by predicting their risk of serious heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil) |
| Trial ID | NCT05954507 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prognostic value of combined PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging) in patients with suspected cardiac sarcoidosis. By improving diagnostic performance, the study seeks to better stratify risks, particularly for sudden cardiac events, and enhance the management of patients through targeted therapies. The hypothesis is that PET/MRI can effectively differentiate between fibrosis and granulomatous lesions, providing valuable insights into the therapeutic response. This innovative approach could lead to improved patient outcomes in managing cardiac sarcoidosis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed sarcoidosis and suspected cardiac involvement.
Not a fit: Patients without suspected cardiac involvement or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the diagnostic accuracy and management of patients with cardiac sarcoidosis.
How similar studies have performed: While the use of PET/MRI is a novel approach in this context, similar imaging techniques have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Créteil
- Henri Mondor Hospital — Créteil, France (Recruiting)
Study contacts
- Study coordinator: Vania TACHER, PHD
- Email: vania.tacher@aphp.fr
- Phone: 01 49 81 29 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.