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NCT Number: NCT06100328

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

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.

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Key information

Age range

3 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in the incidence of MACCE

    Time frame: 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 outcomes

  1. Change in the incidence of all-cause death

    Time frame: 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

  2. Change in the incidence of myocardial infarction

    Time frame: 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

  3. Change in the incidence of coronary revascularization surgery

    Time frame: 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

  4. Change in the incidence of stroke

    Time frame: 1, 3, 6, 12, 24, 36, 48, and 60 months after enrollment.

    Stroke diagnosed by clinical doctors will be assessed from the medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: UNIQUE

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Oct 25, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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