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New treatment option for Cardiac Sarcoidosis
Official title Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis
ClinicalTrials.gov ID: NCT05954507
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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\>...
- 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...
- Informed patient consent
- Membership of a social security scheme
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.