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NCT Number: NCT05569356

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

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.

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Key information

Conditions

Arrhythmogenic Cardiomyopathy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Cardiologie de la Pitié-Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prospective

Biological

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

retrospective

Other

None (only data collection)

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

  5. Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data

    Time frame: 10 years

  6. Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR

    Time frame: 10 years

  7. Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Estelle GANDJBAKHCH, Dr

CONTACT

[email protected]

+33 1 42 16 30 55

Mikael LAREDO, Dr

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: ACORE

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Oct 6, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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