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

ConditionArrhythmogenic Cardiomyopathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients under curatorship/guardianship

Pregnant women

Patients who expressed their opposition to participate in the study

Trial population

All adult patients with clinical or preclinical Arrhythmogenic Cardiomyopathy (carrier of risk mutation). The retrospective patients will be informed by mail and the prospective patients will be informed during their routine care visit, both using the opt-out approach.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Prospective

    Biological/Vaccine

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

  • Retrospective

    Other intervention

    None (only data collection)

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective)1 intervention
Group B: Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective)1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities)

Time frame
10 years
3

Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time

Time frame
10 years
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: