NCT06048458

Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity.

Detailed description

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.

Conditions

• Cardiovascular Diseases
• Cardiotoxicity
• Fluorouracil Adverse Reaction
• Malignancy
• Colorectal Cancer
• Oesophagus Cancer
• Gastric Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiovascular magnetic resonance with stress perfusion	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.
DIAGNOSTIC_TEST	CT coronary angiography	CT coronary angiogram at baseline only in both cohorts to assess for coronary artery disease
DIAGNOSTIC_TEST	Retinal OCT angiography	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.
DIAGNOSTIC_TEST	Sublingual microscopy (GlycoCheck)	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.
DIAGNOSTIC_TEST	Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP)	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.

Timeline

• Start date: 2022-05-18
• Primary completion: 2023-12-01
• Completion: 2024-02-01
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: United Kingdom