Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the incidence of MACCE
研究概览
简要总结
This study aims to retrospectively and prospectively collect clinical and biological specimen data from patients with cardiac tumors who meet the inclusion and exclusion criteria. Various techniques, including general molecular biology analysis and multi-omics analysis, will be used to construct a prognostic model for cardiac tumors.
详细描述
This study aims to construct a retrospective-prospective long-term follow-up cohort and management system for cardiac tumors through a multi-centre collaborative network. The duration of the study will be divided into retrospective and prospective components. The retrospective study will collect cases of cardiac tumors from 2003-2022; the prospective study is expected to collect cases of cardiac tumors from 2022-2030. The study is expected to assess the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of cardiac tumors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are regularly visited and followed up in the corresponding cardiovascular center.
- •All patients must meet at least one of the following diagnostic criteria for cardiac neoplasms:
- •Cardiac myxoma group;
- •Cardiac fibroma group;
- •Cardiac lipoma group;
- •Cardiac hemangioma group;
- •Cardiac undifferentiated sarcoma;
- •Cardiac angiosarcoma group;
- •Cardiac rhabdomyosarcoma group;
- •Cardiac lymphoma group;
- •Cardiac metastasis group;
- •Other cardiac tumors group.
排除标准
- •Age <3 years or >80 years old.
- •Pregnant and lactating women.
- •The patient declined to provide informed consent to participate in the study.
- •None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.
结局指标
主要结局
Change in the incidence of MACCE
时间窗: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
MACCE (major adverse cardiac and cerebrovascular events) including all-cause death, myocardial infarction, coronary revascularization surgery and stroke. The MACCE will be assessed from the medical records.
次要结局
- Change in the incidence of stroke(1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.)
- Change in the incidence of all-cause death(1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.)
- Change in the incidence of myocardial infarction(1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.)
- Change in the incidence of coronary revascularization surgery(1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.)