Defining Robust Predictors of Chemotherapy Related Cardiotoxicity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of fluoropyrimidine induced cardiotoxicity (FIC)
研究概览
简要总结
Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.
详细描述
All enrolled participants will undergo baseline cardiovascular risk assessment (using QRISK3 and SCORE 2 risk calculators), cardiac, oncological and medication history. All participants will have serial cardiac symptom assessment, 12 lead ECG and cardiac biomarker assessments(high sensitivity troponin T and NT pro BNP) at baseline, on completion of the first cycle of treatment and post completion of treatment. Participants will be followed up for the development of cardiotoxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic)
- •Capacity to provide consent
排除标准
- •Lacking capacity to consent
结局指标
主要结局
Incidence of fluoropyrimidine induced cardiotoxicity (FIC)
时间窗: 12 months
Fluoropyrimidine induced cardiotoxicity defined as a composite of: * Types 1-3 myocardial infarction with troponin \>99th percentile upper limit, * Incident myocardial ischaemia (chest pain with or without new inducible perfusion abnormality on perfusion cardiac MRI, * Myocarditis (diagnosed as per European Society of Cardiology Consensus statement) * Incident heart failure (HF) diagnosis (symptoms with raised N-terminal pro-B-type natriuretic peptide (NTproBNP )\> 400pg/ml or HF hospitalisation), * Incident arrhythmia (excluding isolated ectopy) or sudden cardiac death.
Relationship of baseline cardiovascular risk with FIC
时间窗: 12 months
Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator
次要结局
- Change in cardiac biomarkers (high sensitivity troponin T)(Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion))
- Change in cardiac biomarkers (NT pro BNP)(Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion))
- Cardiovascular symptom assessment(Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion))