Viewing Study NCT05450783



Ignite Creation Date: 2024-05-06 @ 5:51 PM
Last Modification Date: 2024-10-26 @ 2:36 PM
Study NCT ID: NCT05450783
Status: NOT_YET_RECRUITING
Last Update Posted: 2022-07-11
First Post: 2022-05-16

Brief Title: Issue 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
Sponsor: Nantes University Hospital
Organization: Nantes University Hospital

Study Overview

Official Title: 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
Status: NOT_YET_RECRUITING
Status Verified Date: 2022-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CharACTPET-MR
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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None