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

Recruiting

• Conditions: Cardiac Tumor

• Registration Number: NCT06100328
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Study Start: 2023-10-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2030-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the incidence of MACCE	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiantong University; 🇨🇳 Xi'an, Shaanxi, China