Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping
NCT ID: NCT06048458
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2022-05-18
2024-02-29
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Stable patients with gastrointestinal malignancies will be recruited to this 3 timepoint study prior to initiation of fluoropyrimidine chemotherapy. All investigations will be performed at baseline, at the end of cycle 1 and 4-6 weeks post completion of treatment.
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.
CT coronary angiography
CT coronary angiogram at baseline only in both cohorts to assess for coronary artery disease
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.
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.
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.
Cohort 2
Patients with gastrointestinal malignancies presenting to hospital with acute symptoms of fluoropyrimidine cardiotoxicity. All investigations will be performed during the acute presentation and the second visit will be performed 4-6 weeks post completion of treatment.
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.
CT coronary angiography
CT coronary angiogram at baseline only in both cohorts to assess for coronary artery disease
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.
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.
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.
Interventions
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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.
CT coronary angiography
CT coronary angiogram at baseline only in both cohorts to assess for coronary artery disease
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Gastrointestinal malignancy
* Receiving fluoropyrimidine chemotherapy
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Charlotte Manisty, PhD
Role: PRINCIPAL_INVESTIGATOR
UCL
Locations
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St Bartholomews Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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142669
Identifier Type: -
Identifier Source: org_study_id
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