The Multicenter Cardiology Monitoring Platform Registry (mCMP-registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40,000
- 试验地点
- 1
- 主要终点
- (sudden) cardiac death or heart transplantation
研究概览
简要总结
The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is a prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional).
It's objective is to optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.
详细描述
Rationale: Heart failure (HF) represents a heterogeneous range of clinical overlapping cardiomyopathy phenotypes, resulting from multifactorial environmental insults in the presence or absence of a genetic predisposition. A better understanding of (early) cardiomyopathy phenotypes, related cardiovascular diseases, their underlying pathophysiological processes, and their related disease burden is key to pave the way for novel preventive and/or intervention studies.
Objective
To optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.
Study design: The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is an investigator-initiated multicentre prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional).
Study population: All subjects aged ≥16 years that have been referred to the cardiology or genetics department for cardiac symptoms, cardiac screening or cardiogenetic screening are eligible for inclusion.
Main study parameters/endpoints: This is a prospective registry from which multiple research questions can be answered. In general, two main approaches will be used: (A) a data-driven (multi-)omics approach which aims to identify clusters of patients to predict clinical outcome, to improve (early) diagnosis, and/or to identify clusters of patients that share underlying pathophysiological processes; (B) a hypothesis-driven approach in which clinical parameters are tested for their (incremental) diagnostic and/or prognostic value.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to the cardiology or genetic department for heart failure like symptoms (as stated in the ESC 2016 Guidelines(3)) or for cardiac/cardiogenetic screening;
- •Age ≥16 years.
排除标准
- •Unwillingness to participate or unable to give written informed consent (e.g. due to language barriers or severe intellectual disability).
结局指标
主要结局
(sudden) cardiac death or heart transplantation
时间窗: through study completion, an average of 15 years
Death attributed to a cardiac cause or sudden, or heart transplantation.
次要结局
- Heart Failure hospitalization(through study completion, an average of 15 years)
- Life-threatening arrhythmias(through study completion, an average of 15 years)
- Quality of life EQ-5D questionnaire(through study completion, an average of 15 years)
- Economic burden(through study completion, an average of 15 years)