Clinical trial · Observational
Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors
Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4
- 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)
Our knowledge on cardiovascular side effects of immune checkpoint inhibitors (ICIs) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). We aim at assessing the incidence of cardiovascular adverse side effects of ICIs by means of a prospective interventional single centre study using multiple biomarkers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Abnormalities | — | UNRESOLVED | — |
| Immune Defect | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biobanking | Other | — | UNRESOLVED |
| Cardiac MRI | Diagnostic Test | — | UNRESOLVED |
| Smart cloth | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- interventionNames
- Diagnostic Test: Cardiac MRI
- Device: Smart cloth
- Other: Biobanking
Primary outcomes (1)
- measure
- Number of patients with major cardiovascular advserse drug reactions
- timeFrame
- 6 weeks
- description
- Incidence of a composite endpoint including myocarditis, pericarditis, acute coronary syndrome, acute heart failure, subclinial cardio-toxicity, high degree conduction abormalities or ventricular sustained arrythmias, cardiovascular death.
Secondary outcomes (5)
- measure
- Number of patients with major cardiovascular advserse drug reactions
- timeFrame
- 6 months
- description
- Incidence of a composite endpoint including myocarditis, pericarditis, acute coronary syndrome, acute heart failure, subclinial cardio-toxicity, high degree conduction abormalities or ventricular sustained arrythmias, cardiovascular death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- prescribed treatment by immune checkpoint inhibitors (ICI) for cancer Exclusion Criteria: * previous treatment by any ICI * any contraindication to cardiac resonance magnetic imaging * contraindication to gadoteric acid, meglumin or any gadolinium-based contrast agent * pace maker or automated implantable defibrilator * pregnancy, breastfeeding * women of childbearing potential who do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion * patient under legal protection * renal failure defined by creatinine clearance \<30ml/min/m² (CKD-EPI) * current participation or exclusion period of another interventional clinical study Exclusion Criteria for ancillary studies: \- hemoglobinemia \< 9 g/dl
References
Publications (0)
Data not yet available