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

Cardiac Tumor Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06100328
• Other study ID #: XJTU1AF2023LSK-284
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: July 31, 2030

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang Li
• Phone: +8613759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 31, 2030
• Est. primary completion date: July 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Tumor

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiantong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.