Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy. (ACORE)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Prospective, Retrospective.
- Кому может быть актуально
- Состояния в реестре: Arrhythmogenic Cardiomyopathy. Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.
Обзор
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.
Подробное описание
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.
Вмешательства
- Биопрепарат Prospective
-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care) - Другое Retrospective
None (only data collection)
Первичные конечные точки
- 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) [Срок оценки: 10 years]
Вторичные конечные точки (7)
- Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging [Срок оценки: 10 years]
- Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities) [Срок оценки: 10 years]
- Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time [Срок оценки: 10 years]
- Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain [Срок оценки: 10 years]
- Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data [Срок оценки: 10 years]
- Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR [Срок оценки: 10 years]
- Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers. [Срок оценки: 10 years]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Patients under curatorship/guardianship
- Pregnant women
- Patients who expressed their opposition to participate in the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Institut de Cardiologie de la Pitié-Salpêtrière — Paris
Идентификаторы
NCT: NCT05569356 · APHP210985 · 2022-A00283-40