Cardiac Amyloidosis Registry Study - A Multi-Center, Longitudinal, Observational Survey of Patients With Cardiac Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 5,000
- 试验地点
- 23
- 主要终点
- Quantify incidence of complications from cardiac amyloidosis
研究概览
简要总结
This registry is a observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025.
详细描述
Amyloidosis is a rare, multisystem disorder in which an insoluble protein is deposited in tissues, leading to organ dysfunction. Several proteins have been identified to potentially lead to amyloid cardiomyopathy (AC). Given the rare nature of these diseases, a large, multi-center effort to describe the characteristics of these patients and their outcomes with novel treatment modalities has not been established. (TBD) academic medical centers from the US and internationally will compile demographic, hemodynamic and organ-involvement data, as well as treatment strategies for AL and TTR amyloidosis.
This registry is an observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025. It is expected that the total patient population will be approximately 5000 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Established diagnosis of AL or TTR cardiomyopathy identified or treated within the timeframe
- •Specific to CSMC: If the individual provided consent while they were alive, and if sufficient information exists in their chart, their data will be included.
- •Information on deceased individuals may be included, but only with the appropriate approval from the external site IRB and/or according to the federal regulations for the protection of human subjects.
排除标准
- •At Cedars-Sinai, records that specifically state not to be used in research will not be accessed. Patients who have enacted a No Research Flag or are noted as "Break the Glass" will not be included. For external sites, records that indicate No Research Flag or are noted as "Break the Glass" may be included based on institutional policies and appropriate approvals, as applicable.
结局指标
主要结局
Quantify incidence of complications from cardiac amyloidosis
时间窗: 1997 - 2025
Determine incidence of arrhythmias (atrial fibrillation; ventricular arrhythmias) after diagnosis, renal dysfunction (rise in creatinine and development of end-stage renal disease), stroke, bleeding complications \[time frame 3 years\]
Quantify disease severity at diagnosis, progression and survival in patients with cardiac amyloidosis
时间窗: 1997 - 2025
Clinical Outcomes: Disease severity at presentation, progression, and survival \[time frame 3 years\]. Severity and progression determined by change in NYHA Class, NT-ProBNP and troponin.
次要结局
未报告次要终点
研究者
Jignesh Patel, MD, PhD
Principal Investigator
Cedars-Sinai Medical Center