Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.
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.
Study Type
OBSERVATIONAL
Enrollment
600
St Bartholomews Hospital
London, United Kingdom
RECRUITINGIncidence of fluoropyrimidine induced cardiotoxicity (FIC)
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.
Time frame: 12 months
Relationship of baseline cardiovascular risk with FIC
Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator
Time frame: 12 months
Relationship of baseline cardiovascular risk with FIC
Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator
Time frame: 12 months
Change in cardiac biomarkers (high sensitivity troponin T)
Time frame: 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)
Time frame: 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
Using modified seattle angina questionnaire
Time frame: 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)
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