Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy. (ACORE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prospective, Retrospective.
- Who it may be relevant to
- Registry conditions: Arrhythmogenic Cardiomyopathy. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.
Overview
This study aims to identify novel inflammatory biomarkers in AC, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients.
Detailed description
The treatment of AC remains based on palliative measures aimed at treating the consequences of the disease: antiarrhythmic treatments, defibrillator, treatments for heart failure. The identification of new biomarkers, in particular circulating ones, would make it possible to open pathophysiology avenues which, in the long term, could lead to therapies targeted to autoimmunity or inflammation.
Many scientific and medical questions remain unanswered and require precise databases on the diagnostic and prognostic evaluation of this pathology.
The objective of this study is to identify novel inflammatory biomarkers in patients with AC by studying the autoimmunity, inflammatory, and immunological profiles through blood samples and myocardial biopsies.
Interventions
- Biological Prospective
-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care) - Other Retrospective
None (only data collection)
Primary outcome measures
- Measure the correlation between the autoimmunity, inflammatory, and immunological profiles through biomarkers found in blood samples, myocardial biopsies, mass imaging cytometry, and cardiac imaging in patients with Arrhythmogenic Cardiomyopathy (AC) [Time frame: 10 years]
Secondary outcome measures (7)
- Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging [Time frame: 10 years]
- Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities) [Time frame: 10 years]
- Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time [Time frame: 10 years]
- Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain [Time frame: 10 years]
- Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data [Time frame: 10 years]
- Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR [Time frame: 10 years]
- Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers. [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Adult patient (age ≥ 18 years old)
- Patient with a probable or confirmed diagnosis of cardiomyopathy according to the diagnostic criteria of the international task force
- Patient carrying a pathogenic mutation responsible for cardiomyopathy
- Patient informed individually of the research
Exclusion criteria
- Patients under curatorship/guardianship
- Pregnant women
- Patients who expressed their opposition to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Institut de Cardiologie de la Pitié-Salpêtrière — Paris
Identifiers
NCT: NCT05569356 · APHP210985 · 2022-A00283-40