Observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity.
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.
Study Type
OBSERVATIONAL
Enrollment
75
Cardiac MRI scan to assess changes in left ventricular function, parametric mapping, strain and myocardial blood flow. In cohort 1 this will be performed pre, during and on completion of treatment. In cohort 2 this will be performed during the acute presentation and on completion of treatment.
CT coronary angiogram at baseline only in both cohorts to assess for coronary artery disease
Retinal OCTa to assess changes in retinal vasculature. In cohort 1 this will be performed pre, during and on completion of treatment. In cohort 2 this will be performed during the acute presentation and on completion of treatment.
St Bartholomews Hospital
London, United Kingdom
RECRUITINGChange in myocardial blood flow from baseline with adenosine stress assessed by quantitative perfusion cardiac MRI
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months
Change in left ventricular ejection fraction from baseline
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months
Change in left ventricular extracellular volume from baseline
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months
Change in left ventricular global longitudinal strain from baseline
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months
Change in N-terminal pro B-type natriuretic peptide (NT-pro BNP)
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months
Change in high sensitivity troponin T
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months
Change in sublingual perfused boundary region
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months
Change in sublingual capillary density
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To determine changes in sublingual microvascular health. In cohort 1 this will be performed pre, during and on completion of treatment. In cohort 2 this will be performed during the acute presentation and on completion of treatment.
Performed to assess for myocardial injury. In cohort 1 this will be performed pre, during and on completion of treatment. In cohort 2 this will be performed during the acute presentation and on completion of treatment.
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months
Change in retinal vessel density
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Time frame: 6 months