Clinical trial · Observational
Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping
NCT06048458CI-TRIAL-00069729PC-TOXunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Fluorouracil Adverse Reaction | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Oesophagus Cancer | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiovascular magnetic resonance with stress perfusion | Diagnostic Test | — | UNRESOLVED |
| CT coronary angiography | Diagnostic Test | — | UNRESOLVED |
| Retinal OCT angiography | Diagnostic Test | — | UNRESOLVED |
| Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP) | Diagnostic Test | — | UNRESOLVED |
| Sublingual microscopy (GlycoCheck) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- 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.
- interventionNames
- 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)
- label
- Cohort 2
- description
- 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.
- interventionNames
- Diagnostic Test: Cardiovascular magnetic resonance with stress perfusion
- Diagnostic Test: CT coronary angiography
- Diagnostic Test: Retinal OCT angiography
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Gastrointestinal malignancy * Receiving fluoropyrimidine chemotherapy Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.