Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients under curatorship/guardianship
- •Pregnant women
- •Patients who expressed their opposition to participate in the study
结局指标
主要结局
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)
时间窗: 10 years
次要结局
- Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time(10 years)
- Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data(10 years)
- Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.(10 years)
- 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)
- Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR(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)