Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

Study Overview
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Brief Summary
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Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.

Detailed Description
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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.

Official Title
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Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

Conditions
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Cardiotoxicity, Gastrointestinal Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic) Capacity to provide consent Exclusion Criteria: Age <18 Lacking capacity to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence 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. | 12 months | 
| Relationship of baseline cardiovascular risk with FIC | Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator | 12 months | 
| Relationship of baseline cardiovascular risk with FIC | Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Using modified seattle angina questionnaire | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluoropyrimidine, Cardiotoxicity, Cardio-oncology