Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy. (ACORE)
ACORE
Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.
2 other identifiers
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedStudy Start
First participant enrolled
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 20, 2032
October 13, 2022
March 1, 2022
10 years
September 14, 2022
October 11, 2022
Conditions
Keywords
Outcome Measures
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)
10 years
Secondary Outcomes (7)
Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging
10 years
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 time
10 years
Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain
10 years
Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data
10 years
- +2 more secondary outcomes
Study Arms (2)
Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective)
Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective)
Interventions
-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care)
None (only data collection)
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients under curatorship/guardianship
- Pregnant women
- Patients who expressed their opposition to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Cardiologie de la Pitié-Salpêtrière
Paris, 75013, France
Biospecimen
Plasma, Serum, PBMC, pericardial fluid, myocarditis biopsy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Estelle GANDJBAKHCH, Dr
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2022
First Posted
October 6, 2022
Study Start
October 20, 2022
Primary Completion (Estimated)
October 20, 2032
Study Completion (Estimated)
October 20, 2032
Last Updated
October 13, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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
- Access Criteria
- Researchers who provide a methodologically sound proposal
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.