Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in myocardial blood flow from baseline with adenosine stress assessed by quantitative perfusion cardiac MRI
研究概览
简要总结
Observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity.
详细描述
Fluoropyrimidine (5-FU and Capecitabine) based chemotherapy regimens form the cornerstone of treatments for gastrointestinal (GI) cancers. Fluoropyrimidines however, are associated with the development of cardiovascular toxicity which can take on different forms including chest pain, myocardial infarction, arrhythmias, heart failure and sudden death. The underlying mechanisms of cardiovascular toxicity are not fully understood.
The investigators will use quantitative cardiovascular magnetic resonance perfusion imaging, CT coronary angiography, extra-cardiac vascular assessments and serum cardiac biomarkers to improve insights into the pathophysiology of fluoropyrimidine cardiotoxicity. All enrolled participants in this two centre study will have GI cancers requiring treatment with fluoropyrimidine chemotherapy.
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
- 是
入选标准
- •Age >18 years
- •Gastrointestinal malignancy
- •Receiving fluoropyrimidine chemotherapy
排除标准
- •Participants unable or unwilling to provide consent
- •Participants that have a conventional contraindication for magnetic resonance imaging (MRI) including permanent implantable cardiac devices, ferromagnetic implants, pregnancy, large body size not fitting into the scanner bore and severe claustrophobia will be excluded
- •Participants that have a conventional contraindication for adenosine stress perfusion including a history of trifascicular block or of second-degree heart block or higher on ECG, or uncontrolled asthma.
- •Participants with significant renal impairment (eGFR<30ml/min)
- •History of allergy to adenosine, gadolinium or iodinated contrast
- •Patients with terminal illness (life expectancy <6 months) will be excluded.
结局指标
主要结局
Change in myocardial blood flow from baseline with adenosine stress assessed by quantitative perfusion cardiac MRI
时间窗: 6 months
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
次要结局
- Change in left ventricular extracellular volume from baseline(6 months)
- Change in sublingual perfused boundary region(6 months)
- Change in left ventricular global longitudinal strain from baseline(6 months)
- Change in sublingual capillary density(6 months)
- Change in high sensitivity troponin T(6 months)
- Change in N-terminal pro B-type natriuretic peptide (NT-pro BNP)(6 months)
- Change in retinal vessel density(6 months)
- Change in left ventricular ejection fraction from baseline(6 months)