Cancer, Cancer;Cardiovascular;Adverse Events
Conditions
Brief summary
This study will prospectively monitor cancer patients receiving chemotherapy (including molecular targeted therapies) for cardiovascular adverse events using biomarkers and imaging. The goal is to develop a predictive model for major adverse cardiovascular events (MACE) in this population by integrating both local factors (e.g. central venous catheter-related thrombosis) and systemic factors (e.g. age, comorbidities, genetic predisposition). An active surveillance system employing periodic cardiac evaluations (ECG, echocardiography) and biomarker measurements (troponin T, NT-proBNP) will enable early detection of cardiotoxic effects. The impact of these adverse events and the monitoring strategy on patients' quality of life will also be assessed.
Detailed description
Cancer patients are at heightened risk of cardiovascular complications due to both their disease and its treatments. Many chemotherapeutic and targeted agents (e.g. anthracyclines, trastuzumab, bevacizumab, tyrosine kinase inhibitors) carry cardiotoxic potential, leading to diverse manifestations of MACE such as heart failure, arrhythmias, ischemic heart disease, valvular dysfunction, hypertension, thromboembolism, and others. As cancer survival improves and newer therapies are widely used, the incidence of treatment-related cardiac toxicity continues to rise. Early cardiotoxic changes are often subclinical, making proactive monitoring essential. Research has shown that cardiac biomarkers can rise before left ventricular ejection fraction declines, enabling pre-symptomatic detection of cardiotoxicity. By quantitatively analyzing the predictive value of each indicator for MACE, the study aims to construct a comprehensive risk prediction model for precise cardiovascular risk evaluation in cancer patients. Both local risk factors (e.g., indwelling catheter-related thrombosis) and systemic factors (e.g., age, hypercoagulability, body mass index) will be incorporated, reflecting the interplay of factors contributing to MACE. Genetic biomarkers will also be explored: blood samples are collected for genomic analysis (such as SNP genotyping and whole genome sequencing) to identify genetic polymorphisms associated with increased susceptibility to therapy-related MACE. By comparing patients who develop cardiovascular events to those who do not, we will characterize the incidence, timing, affected organs, and clinical presentation of MACE in cancer patients. Patient-reported quality of life will be evaluated using validated questionnaires, to determine how the occurrence of adverse cardiovascular events (and the implementation of active monitoring) affects daily functioning and overall well-being. Ultimately, this study's findings will provide a scientific basis for individualized risk stratification and preventive interventions in cardio-oncology, supporting optimized clinical strategies to mitigate cardiovascular risk without compromising effective cancer treatment.
Interventions
None listed
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Adults (age \> 18 years) with a pathologically confirmed malignant tumor (any type of cancer); 2.Currently receiving or planning to receive chemotherapy (including regimens containing molecular targeted drugs) as adjuvant treatment for cancer; 3.Willing and able to participate in the study with provision of informed consent, and agreeable to provide required clinical data and biological samples. \-
Exclusion criteria
1. Incomplete basic patient information or medical records (missing key data necessary for the study); 2. Failure to complete the full course of planned chemotherapy at the study center (e.g., patient did not adhere to or finish all cycles of adjuvant chemotherapy at our institution); 3. History of severe acute cardiovascular or cerebrovascular events within 6 months prior to enrollment, including acute heart failure, acute myocardial infarction, acute intracerebral hemorrhage (stroke), malignant arrhythmia, or New York Heart Association (NYHA) Class IV/V heart failure; 4. Missing essential pre- or post-chemotherapy evaluations: patients who did not undergo complete baseline or end-of-treatment assessments (such as blood routine, hepatic/renal function, coagulation profile, cardiac enzymes (troponin T), NT-proBNP (or BNP), 12-lead ECG, and echocardiogram)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of New Onset Major Adverse Cardiovascular Events (MACE) by End of Chemotherapy | From initiation of chemotherapy to end of adjuvant chemotherapy (approximately up to 6 months per patient). | Occurrence of any new cardiovascular adverse event from start of chemotherapy to the completion of the chemotherapy regimen. MACE is defined per ESC guidelines to include major cardiac events such as new myocardial dysfunction, symptomatic heart failure, coronary artery disease (e.g. myocardial infarction), clinically significant valvular disease, arrhythmia (e.g. atrial fibrillation), new or worsening hypertension, thromboembolic events (including deep vein thrombosis or pulmonary embolism), peripheral vascular disease, pulmonary hypertension, or pericardial disease. Any such event recorded on electrocardiogram, cardiac ultrasound (echocardiography), or via cardiac enzymes (troponin T) and biomarkers (NT-proBNP/BNP) by the end of the adjuvant chemotherapy cycle, relative to the patient's pre-treatment baseline, will be counted as an outcome event. (Early cardiovascular events are defined as those occurring during the chemotherapy period.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score Change (Baseline to 6 Months Post-treatment) | Baseline pre-therapy and 6 months after completion of chemotherapy. | Change in patient-reported quality of life from baseline (pre-therapy) to follow-up after therapy completion. Quality of life will be measured using a validated questionnaire (e.g., EORTC QLQ-C30 or similar cancer-specific QoL instrument) at study entry and at 6 months after the last chemotherapy cycle. The difference in global health/QoL scores and functional subscales will be analyzed to determine the impact of any adverse events and the monitoring program on patients' quality of life. |
Countries
China
Contacts
Primary Contactxiaoyan li
Outcome results
None listed