Clinical trial NCT06100328: Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE)
Official title: Characteristics of Cardiac Tumor and the Risk Stratification of Subsequent Adverse Events (UNIQUE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Tumor
Keywords: Cardiac tumor
Disease characteristics
Prognosis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Primary outcomes:
measure: Change in the incidence of MACCE
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Secondary outcomes:
measure: Change in the incidence of all-cause death
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
measure: Change in the incidence of myocardial infarction
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
measure: Change in the incidence of coronary revascularization surgery
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
measure: Change in the incidence of stroke
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References: