INFLAMMATORY AND IMMUNE-MEDIATED DISEASES BIOBANKING FOR IMMUNOPHENOTYPING AND CARDIOVASCULAR RESEARCH
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Proportion of participants experiencing major adverse cardiovascular events (MACE) within 1 year of follow-up.
研究概览
简要总结
INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs).
The primary objective is to identify immune biomarkers associated with cardiovascular prognosis and develop disease-specific prognostic scores to predict 1-year major adverse cardiovascular events (MACE). Secondary objectives include evaluating the diagnostic and prognostic value of immunoproteomic biomarkers, assessing the role of photon-counting CT (PCCT) imaging, and investigating immune signatures associated with genetic variants in acute myocarditis.
The study plans to enroll 300 patients from French centers participating in EACVI-INFLAME. Blood samples will be collected during routine clinical care at inclusion, with optional follow-up sampling at 12 months and optional PCCT imaging and genetic analyses depending on each center's participation. Patients will be followed for 12 months to monitor cardiovascular outcomes.
The expected impact is to improve understanding of the immune mechanisms underlying ICARDs, facilitate earlier diagnosis and risk stratification, identify new therapeutic targets, and ultimately support more personalized management of patients with inflammatory cardiovascular diseases.
详细描述
Detailed Description
INFLAME-BANK is a French multicenter prospective observational study conducted as an ancillary project of the international EACVI-INFLAME study. Its purpose is to establish a biobank of blood samples and perform advanced immunophenotyping and proteomic analyses in patients with suspected cardiovascular involvement related to inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs).
The main objective of the study is to identify immune and proteomic biomarkers associated with cardiovascular prognosis and to develop disease-specific prognostic scores capable of predicting major adverse cardiovascular events (MACE) at 1 year. The primary endpoint is the proportion of patients experiencing MACE after one year of follow-up.
Secondary objectives include:
Characterizing baseline immunological and proteomic profiles in patients with suspected or confirmed ICARDs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient enrolled in EACVI-INFLAME study
- •The patient consents
排除标准
- •Patients with a history of heart transplant
- •Patient unable to provide informed consent
- •Patient under complete or limited guardianship
- •Patient affected by pre-existing immunodeficiency, including HIV (not including immunosuppressive treatment)
结局指标
主要结局
Proportion of participants experiencing major adverse cardiovascular events (MACE) within 1 year of follow-up.
时间窗: 1years
Occurrence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, hospitalization for heart failure, myocardial infarction, incidental atrial fibrillation, stroke, and recurrent ICARD, assessed at 1 year after inclusion.
次要结局
未报告次要终点