Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study

Conditions
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Cardiac Tumor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 1. Cardiac myxoma group; 2. Cardiac fibroma group; 3. Cardiac lipoma group; 4. Cardiac hemangioma group; 5. Cardiac undifferentiated sarcoma; 6. Cardiac angiosarcoma group; 7. Cardiac rhabdomyosarcoma group; 8. Cardiac lymphoma group; 9. Cardiac metastasis group; 10. Other cardiac tumors group. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac myxoma group<br>patients who are diagnosed as cardiac myxoma | |
| Cardiac fibroma group<br>patients who are diagnosed as cardiac fibroma | |
| Cardiac lipoma group<br>patients who are diagnosed as cardiac lipoma | |
| Cardiac hemangioma group<br>patients who are diagnosed as cardiac hemangioma | |
| Cardiac malignant tumor group<br>patients who are diagnosed as cardiac malignant tumor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the incidence of MACCE | 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. | 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the incidence of all-cause death | All-cause death diagnosed by clinical doctors will be assessed from the medical records | 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment. | 
| Change in the incidence of myocardial infarction | Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records | 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment. | 
| Change in the incidence of coronary revascularization surgery | Coronary revascularization surgery completed by clinical doctors will be assessed from the medica records | 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment. | 
| Change in the incidence of stroke | Stroke diagnosed by clinical doctors will be assessed from the medical records | 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disease characteristics, Cardiac tumor, Prognosis