Cardiovascular DiseasesPC-TOXNCT06048458
Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping
An observational study of Cardiovascular Diseases and Cardiotoxicity, run by University College, London at 1 site in United Kingdom.
Trial summary
Observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiotoxicity, Fluorouracil Adverse Reaction
- What is being tested?
- Cardiovascular magnetic resonance with stress perfusion, CT coronary angiography and Retinal OCT angiography
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2022to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with gastrointestinal malignancies being treated with a fluoropyrimidine based chemotherapy regimen.
Who may be able to join
- Age >18 years
- Gastrointestinal malignancy
- Receiving fluoropyrimidine chemotherapy
Who cannot join
- Participants unable or unwilling to provide consent
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomews Hospital
London, EC1A 7BE
Aderonke Abiodun, MBChB, aderonketemilade.abiodun@nhs.net
Charlotte Manisty, PhD
About this study
Observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity.
Read the 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
- Being tested
- Cardiovascular magnetic resonance with stress perfusion, CT coronary angiography, Retinal OCT angiography, Sublingual microscopy (GlycoCheck), Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP)
- Keywords
- Cardio-oncology, Cardiotoxicity, Fluoropyrimidine cardiotoxicity
- Medical subject headings
- Cardiovascular Diseases, Cardiotoxicity, Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular magnetic resonance with stress perfusionDiagnostic test
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 angiographyDiagnostic test
CT coronary angiogram at baseline only in both cohorts to assess for coronary artery disease
Retinal OCT angiographyDiagnostic test
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)Diagnostic test
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)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cardiovascular magnetic resonance with stress perfusion; Diagnostic Test: CT coronary angiography; Diagnostic Test: Retinal OCT angiography; Diagnostic Test: Sublingual microscopy (GlycoCheck); Diagnostic Test: Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP) | |
| 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. Receives: Diagnostic Test: Cardiovascular magnetic resonance with stress perfusion; Diagnostic Test: CT coronary angiography; Diagnostic Test: Retinal OCT angiography; Diagnostic Test: Sublingual microscopy (GlycoCheck); Diagnostic Test: Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 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
Measured: 6 months
Secondary outcomes (8)
Change in left ventricular ejection fraction from baseline
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Measured: 6 months
Change in left ventricular extracellular volume from baseline
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Measured: 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
Measured: 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
Measured: 6 months
Change in high sensitivity troponin T
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Measured: 6 months
Change in sublingual perfused boundary region
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Measured: 6 months
Change in sublingual capillary density
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Measured: 6 months
Change in retinal vessel density
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 May 2022
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Manisty, PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048458
- Sponsor's protocol ID
- 142669
- Acronym
- PC-TOX
- Status last verified
- Dec 2022
- First submitted
- 27 Apr 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping
- ClinicalTrials.gov ID
- NCT06048458
- Acronym / sponsor ID
- PC-TOX / 142669
- Conditions
- Cardiovascular Diseases, Cardiotoxicity, Fluorouracil Adverse Reaction, Malignancy, Colorectal Cancer, Oesophagus Cancer
- Keywords
- Cardio-oncology, Cardiotoxicity, Fluoropyrimidine cardiotoxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: Cardiovascular magnetic resonance with stress perfusion, Diagnostic Test: CT coronary angiography, Diagnostic Test: Retinal OCT angiography, Diagnostic Test: Sublingual microscopy (GlycoCheck), Diagnostic Test: Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP)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. |
| Cohort 2 | – | Diagnostic Test: Cardiovascular magnetic resonance with stress perfusion, Diagnostic Test: CT coronary angiography, Diagnostic Test: Retinal OCT angiography, Diagnostic Test: Sublingual microscopy (GlycoCheck), Diagnostic Test: Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with gastrointestinal malignancies being treated with a fluoropyrimidine based chemotherapy regimen.
Key inclusion criteria (3 listed)
- Age >18 years
- Gastrointestinal malignancy
- Receiving fluoropyrimidine chemotherapy
Key exclusion criteria (6 listed)
- Participants unable or unwilling to provide consent
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular magnetic resonance with stress perfusionCardiac 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 | Cohort 1, Cohort 2 |
| CT coronary angiographyCT coronary angiogram at baseline only in both cohorts to assess for coronary artery disease | Diagnostic test | Cohort 1, Cohort 2 |
| Retinal OCT angiographyRetinal 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 | Cohort 1, Cohort 2 |
| 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 | Cohort 1, Cohort 2 |
| 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. | Diagnostic test | Cohort 1, Cohort 2 |
Primary outcome
Change in myocardial blood flow from baseline with adenosine stress assessed by quantitative perfusion cardiac MRI
Time frame: 6 months
Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment
8 secondary outcomes
Change in left ventricular ejection fraction from baseline
Time frame: 6 months
Change in left ventricular extracellular volume from baseline
Time frame: 6 months
Change in left ventricular global longitudinal strain from baseline
Time frame: 6 months
Change in N-terminal pro B-type natriuretic peptide (NT-pro BNP)
Time frame: 6 months
Change in high sensitivity troponin T
Time frame: 6 months
Change in sublingual perfused boundary region
Time frame: 6 months
Change in sublingual capillary density
Time frame: 6 months
Change in retinal vessel density
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Manisty, PhD principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiotoxicity, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aderonke Abiodun, MBChB (02073777000, aderonketemilade.abiodun@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in myocardial blood flow from baseline with adenosine stress assessed by quantitative perfusion cardiac MRI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.