NCT05450783 Tissue and Metabolic Characterization of Arrhythmogenic Cardiomyopathies by Hybrid PET-MRI Imaging, Impact of the Observed Profiles on the Phenotype and on the Evolution of Cardiomyopathy
| NCT ID | NCT05450783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Arrhythmogenic Cardiomyopathies |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2022-09-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation. Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis). Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data. Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.
Eligibility Criteria
Inclusion Criteria: * Male and female over 16 years old Exclusion Criteria: * Patients and their relatives with left ventricular or biventricular AC and carrier of a pathogenic or likely pathogenic variant in one of the following genes : PKP2, DSG2, DSC2, JUP, DSP, DES, FLNC, PLN, LMNA, TMEM43, CDH2, BAG3, RYR2, RBM20 Consent form Exclusion Criteria : * Sarcoidosis or known or diagnosed autoimmune disease * History of myocardial infarction * Patient under guardianship, curatorship or safeguard of justice
Contact & Investigator
Nicolas Piriou, PH
PRINCIPAL INVESTIGATOR
Nantes University Hospital
Frequently Asked Questions
Who can join the NCT05450783 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 99 Years, studying Arrhythmogenic Cardiomyopathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05450783 currently recruiting?
Yes, NCT05450783 is actively recruiting participants. Contact the research team at nicolas.piriou@chu-nantes.fr for enrollment information.
Where is the NCT05450783 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Nantes, France, Paris, France and 1 additional location.
Who is sponsoring the NCT05450783 clinical trial?
NCT05450783 is sponsored by Nantes University Hospital. The principal investigator is Nicolas Piriou, PH at Nantes University Hospital. The trial plans to enroll 80 participants.