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

October 11, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75013
        • Institut de Cardiologie de la Pitié-Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective)
Biological: Prospective
-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care)
Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective)
Other: Retrospective
None (only data collection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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)
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
10 years
Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities)
Time Frame: 10 years
10 years
Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time
Time Frame: 10 years
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
10 years
Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data
Time Frame: 10 years
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
10 years
Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Estelle GANDJBAKHCH, Dr, Assistance Publique - Hopitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 20, 2022

Primary Completion (Anticipated)

October 20, 2032

Study Completion (Anticipated)

October 20, 2032

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210985
  • 2022-A00283-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

IPD Sharing Time Frame

Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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