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Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy. (ACORE)

Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05569356
Acronym
ACORE
Enrollment
300
Registered
2022-10-06
Start date
2022-10-20
Completion date
2032-10-20
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmogenic Cardiomyopathy

Keywords

Arrhythmogenic Cardiomyopathy, Inflammatory biomarkers, Autoantibodies

Brief summary

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

BIOLOGICALProspective

-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care)

None (only data collection)

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Adult patient (age ≥ 18 years old) 2. Patient with a probable or confirmed diagnosis of cardiomyopathy according to the diagnostic criteria of the international task force 3. Patient carrying a pathogenic mutation responsible for cardiomyopathy 4. Patient informed individually of the research

Exclusion criteria

1. Patients under curatorship/guardianship 2. Pregnant women 3. Patients who expressed their opposition to participate in the study

Design outcomes

Primary

MeasureTime frame
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)10 years

Secondary

MeasureTime frame
Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities)10 years
Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time10 years
Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain10 years
Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging10 years
Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR10 years
Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.10 years
Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data10 years

Countries

France

Contacts

Primary ContactEstelle GANDJBAKHCH, Dr
estelle.gandjbakhch@aphp.fr+33 1 42 16 30 55
Backup ContactMikael LAREDO, Dr
mikael.laredo@aphp.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026