Prospective Investigation of Cardiovascular Risk Factors in Tumor Patients

• Conditions: Cardioncology
• Interventions: Other: Record general information

• Registration Number: NCT03537339
• Lead Sponsor: Peking Union Medical College

Brief Summary

In this study, prospective cohort study was used to collect the general information of patients' sex, age, previous history, family history, electrocardiogram, echocardiography, cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment of the patients who diagnosed cancer by pathology in National Cancer Center/ Cancer Hospital , Chinese Academy of Medical Sciences and Peking Union Medical College from January 2018 to December 2020. This study intends to evaluate and screen the cardiovascular risk of tumor patients during antitumor therapy and to establish a model of cardiovascular risk assessment for tumor patients, providing clinical evidence for the prevention of cardiovascular disease risk associated with cancer patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-27
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Diagnosis of malignant tumor by pathology or cytology
2. Age 18-80, KPS > 70
3. Epidemiological information, clinical diagnosis and treatment and key information of medication are not missing.
4. The liver and kidney function were in the normal range.
5. All selected patients signed informed consent.

Exclusion Criteria

1. patients diagnosed with congenital heart disease, cardiomyopathy, heart failure, arrhythmia, myocardial ischemia and myocardial infarction within 6 months before enrollment.
2. Severe impairment of liver and kidney function.
3. Left ventricular ejection fraction < 50% by echocardiographic examination.
4. Diagnosis of more than one kind of tumor at the same time.
5. History of surgery and trauma within 3 months before enrollment.
6. Poor compliance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation	Record general information	Record general information of patients' sex, age, previous history, family history, electrocardiogram, echocardiography, cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment and so on

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs) related to Cardio-oncology	January 2018 to December 2020.	Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0) recorded by ECGs,UCGs and myocardial enzyme

Trial Locations

Locations (1)

Fei Ma; 🇨🇳 Beijing, Beijing, China