Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Tumor. Basic parameters: 3 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study
Overview
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
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.
Primary outcome measures
- Change in the incidence of MACCE [Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.]
Secondary outcome measures (4)
- Change in the incidence of all-cause death [Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.]
- Change in the incidence of myocardial infarction [Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.]
- Change in the incidence of coronary revascularization surgery [Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.]
- Change in the incidence of stroke [Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- First Affiliated Hospital of Xi'an Jiantong University — Xi'an
Identifiers
NCT: NCT06100328 · XJTU1AF2023LSK-284