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

NCT ID: NCT05569356

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-20

Study Completion Date

2032-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arrhythmogenic Cardiomyopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective)

Prospective

Intervention Type BIOLOGICAL

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

Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective)

Retrospective

Intervention Type OTHER

None (only data collection)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prospective

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

Intervention Type BIOLOGICAL

Retrospective

None (only data collection)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Estelle GANDJBAKHCH, Dr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut de Cardiologie de la Pitié-Salpêtrière

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Estelle GANDJBAKHCH, Dr

Role: CONTACT

+33 1 42 16 30 55

Mikael LAREDO, Dr

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-A00283-40

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210985

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biomarkers in Acute Cardiac Care
NCT02355457 RECRUITING
PRE-DETERMINE Cohort Study
NCT01114269 ACTIVE_NOT_RECRUITING
Cohort of STEMI Patients 2
NCT05794022 RECRUITING NA